Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative
Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative
Terumo Corporation
Human Prescription Drug
NDC 53877-008Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative also known as Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative is a human prescription drug labeled by 'Terumo Corporation'. National Drug Code (NDC) number for Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative is 53877-008. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative drug includes . The currest status of Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative drug is Active.
Drug Information:
| Drug NDC: | 53877-008 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Terumo Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 05 May, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | BN880217 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Terumo Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53877-008-81 | 18 BAG in 1 CASE (53877-008-81) / 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG | 05 May, 2010 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Teruflex blood bag system with diversion blood sampling arm anticoagulant citrate phosphate dextrose (cpd) and optisol (as-5) red cell preservative anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative anticoagulant citrate phosphate dextrose (cpd) anticoagulant citrate phosphate dextrose (cpd) trisodium citrate dihydrate anhydrous citric acid sodium phosphate, monobasic, unspecified form phosphate ion sodium cation dextrose monohydrate anhydrous dextrose anhydrous citric acid anhydrous citric acid water optisol red cell preservative as-5 red cell preservative sodium chloride sodium cation dextrose monohydrate anhydrous dextrose mannitol mannitol adenine adenine water
Indications and Usage:
Issued 6/03 teruflex® blood bag system with diversion blood sampling arm® cpd/optisol® solution read these instructions carefully before use. rx only. the diversion blood sampling arm⢠is intended to divert and collect blood for obtaining donor test samples. ⢠for single use only. sterile and non-pyrogenic fluid path. sterilized by steam. ⢠intended for the collection, processing and preservation of human blood and components. precautions ⢠do not use unless the solutions are clear. ⢠avoid excessive heat and direct sunlight. protect from freezing. ⢠recommended storage conditions: room temperature (15-30°c/59-86°f). ⢠the blood bag configuration is specified on the blister pack label. caution do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose. instructions for blood collection: use aseptic technique materials needed: venoject® ll tube hold
Read more...er (code p-1316r) or equivalent venoject® ll multi-sample luer adapter (code mn *2000t) or equivalent evacuated blood collection tubes (glass or plastic) 1. prepare the blood bag following your institution's standard operating procedures. 2. if applicable, make a loose knot in the donor tubing below the "y" and cliktip⢠(inline closure device) unless alternate methods are used to seal the tubing at the end of collection. 3. temporarily clamp the donor tubing between the phlebotomy needle and the "y". 4. close the white clamp below the diversion pouch. 5. tube holder/luer adapter assembly: a) connect the venoject ii multi-sample luer adapter to the venoject ii tube holder (or equivalent) (fig.1). insert fig. 1 here b) twist and snap to remove the blue port cap at the end of the diversion blood sampling arm (fig. 2a). c) connect the multi-sample luer adapter to the female luer port. (fig. 2b) note: alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch. insert fig. 2a and 2b here 6. suspend the collection bag as far as possible below the donor's arm. 7. apply blood pressure cuff or tourniquet to donor's arm. disinfect site of phlebotomy. if blood pressure cuff is used, inflate to approximately 60 mmhg. 8. remove the needle cover and perform phlebotomy. remove the temporary clamp on the donor tubing to permit blood flow into the diversion blood sampling arm pouch. caution do not touch the needle after removing the needle protector. assure that the white clamp below the pouch is closed prior to initiating phlebotomy. 9. if using a needle safety device, follow the manufacturer's instructions to secure the device in place. 10. appropriately secure donor tubing to donor's arm. 11. position the diversion pouch with the notches up and the tube holder/luer adapter assembly (or port cap) down. when the level of blood in the pouch is approximately in line with the notches, the diversion pouch is full. (fig. 3a) note: the approximate fill volume of the pouch at the notches is 35 ml. 12. permanently seal the tubing between the "y" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (fig. 3b) 13. to initiate blood flow into the collection bag, break the cllktip between the "y" and the primary bag. 14. to avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (fig. 3b) caution do not collect donor test samples until the tubing between the "y" and the diversion pouch is permanently sealed. a) open the white clamp on the tubing below the pouch to open the pathway for sampling. b) position the diversion pouch with the notches up and the tube holder/luer adapter assembly down. assure that any air in the pouch is at the top and will not enter the blood collection tubes. c) insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. repeat to collect additional samples. note: the pouch may be removed after the donor test samples are collected. a second seal must be made between the diversion pouch and the permanent seal prior to removing the pouch. insert fig. 3a and 3b here 15. once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. collect labeled volume of blood (+/â10%). 17. when the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. make a second seal between the first seal or knot and the cllktip below the "y". various methods may be used to seal tubing. 18. release pressure on the donor's arm and remove the needle. if using a needle safety device, follow the manufacturer's instructions to remove the needle. sever the donor tubing between the two seals previously made below the cllktip and "y". caution discard the diversion blood sampling arm and phlebotomy needle/donor tubing according to institutional procedures. 19. immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed. 20. strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. seal on or near the x marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing. 21. the time of addition of optisol solution may vary depending on the processing option selected. add the solution under one of the following conditions after removal of plasma: a) within 8 hours of whole blood collection, if components are prepared. b) within 72 hours of collection if whole blood is refrigerated immediately following collection. 22. centrifuge the unit to separate red cells from plasma. 23. break the cllktip of primary collection bag and transfer the plasma into the satellite bag. clamp transfer tubing of satellite bag. 24. break the cllktip of optlsol solution bag and drain contents into primary bag containing red blood cells. seal tubing of primary bag in two places, and cut between seals and separate from satellite bag(s). note: for teruflex double bags, seal optisol solution bag tubing in two places and cut between seals. discard optisol solution container. 25. invert the red cell- optisol mixture several times to insure the final as-5 red cell product is well suspended. 26. store as-5 red blood cells between 1-6°c. 27. infuse as-5 red blood cells within 42 days of collection. for further processing, use standard component processing techniques. to open blister package, peel cover film back four fifths of its length. after opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture. insert fig. 4 here cautions â¢the packet of ageless contained in this package absorbs oxygen and generates heat on removal. handle it with care. ⢠dispose with packet in tray. ⢠do not dispose with wastes containing volatile or flammable materials. ⢠discard ageless packet without opening. n-bb-op-a2(db) 1 terumo ® manufactured by: terumo corporation 44-1, 2-chome, hatagaya, shibuya-ku, tokyo, japan made in japan ®: registered trademark diversion blood sampling arm and cliktip are trademarks of terumo corporation. © terumo corporation 2003 03f10 image fig. 1 (attach luer adapter to tube holder) image of fig. 2a and fig. 2b (dbsa) image of fig. 3a and fig. 3b (filling dbsa) image figure sealing with tape
Package Label Principal Display Panel:
Tray/case label teruflex® blood bag system with diversion blood sampling arm® cpd with optisol® red cell preservative solution for collection of 450ml of blood each unit consists of a collection bag containing 63ml of anticoagulant cpd solution, with a satellite bag containing 100ml of optlsol red cell preservative solution. each 63ml anticoagulant cpd solution usp contains 1.61g dextrose (monohydrate) usp, 1.66g sodium citrate (dihydrate) usp, 188mg citric acid (anhydrous) usp, 140mg monobasic sodium phosphate (monohydrate) usp. each 100ml optisol red cell preservative solution contains 877mg sodium chloride usp, 900mg dextrose (monohydrate) usp, 525mg mannitol usp, 30mg adenine usp. sterile, non-pyrogenic fluid path. do not use unless anticoagulant is clear. code lot no. expiry units donor needle 16g x 1 1/2Ë (1.60 x 38mm) rx only recommended storage: room temperature (15-30°c/59-86°f). avoid excessive heat. protect from freezing. after opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture. see instructions for blood collection. manufactured by : terumo corporation tokyo, japan ® : registered trademark diversion blood sampling arm is a trademark of terumo corporation. issued 05/03 b-4-g6-a2 1 place label here image of representative tray/case label cpd-opt 450ml with dbsa