Teruflex Blood Bag System With 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 53877-009Teruflex Blood Bag System With 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 Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative is 53877-009. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Teruflex Blood Bag System With 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 Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative drug is Active.
Drug Information:
| Drug NDC: | 53877-009 |
| 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 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 |
|---|
| 53877-009-41 | 24 BAG in 1 CASE (53877-009-41) / 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 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 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 8/96 teruflex® blood bag system with blood sampling arm® cpd/optisol® solution read these instructions carefully before use. instructions for blood collection: use aseptic technique materials needed: venoject® ll tube holder (code p-1316r) venoject® ll multi-sample luer adapter (code mn *2000) venoject® ll plastic blood collection tubes (or equivalent glass or plastic evacuated blood collection tube) 1. confirm that all numbered tubing of each blood bag unit contains segment numbers. 2. make a loose knot in donor tubing below "y" unless alternate methods are used to seal tubing. 3. clamp donor tubing. 4. suspend primary bag as far as possible below the donor's arm. 5. apply blood pressure cuff or tourniquet to donor's arm. disinfect site of phlebotomy. if blood pressure cuff is used, inflate cuff to approximately 60 mmhg. 6. remove needle protector and perform phlebotomy. remove clamp to permit blood flow into primary bag. caution do not touch needle after remo
Read more...ving the needle protector. 7. appropriately secure donor tubing to donor's arm. 8. mix blood with anticoagulant at several intervals during collection. 9. collect labeled volume of blood (+/â10%). 10. tighten knot firmly after collection. clamp between knot and "y". sever donor tubing between the knot and clamp. alternate methods may be used to seal tubing. caution do not use the dielectric tube sealer while the needle is connected to the donor's body. anytime before step #13 below, sever donor tubing between the two seals. collect blood samples as follows: a) connect venoject ii multi-sample luer adapter to venoject ii tube holder (fig. 1). b) remove covers and connect multi-sample luer adapter to female luer at end of donor sampling tubing (fig. 2). c) snap cliktip in donor sampling tubing to open blood pathway. insert fig. 1 here insert fig. 2 here d) insert blood collection tube (venoject ii or equivalent) firmly into venoject ii tube holder : when full, remove sample tube from holder. repeat to collect additional samples. 11. reapply clamp to donor tubing between phlebotomy needle and "y"; release pressure on donor's arm and remove needle. caution discard tubing/phlebotomy needle unit according to institutional procedures. 12. immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed. 13. strip blood from the donor tubing into bag, mix well, and allow tubing to refill. seal on or near x marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing. 14. the time of addition of optisol solution may vary depending on the processing option selected. add the solution under one of the following conditions. a) after removal of plasma from freshly collected blood. b) within 8 hours of blood collection if components are prepared. c) within 72 hours of collection if blood is refrigerated immediately following collection. 15. centrifuge the unit to separate red cells from plasma. 16. snap cllktip (inline closure device) of primary collection bag and transfer plasma into satellite bag. clamp transfer tubing of satellite bag. 17. snap 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. 18. invert the red cell- optisol mixture several times to insure the final as-5 red cell product is well suspended. 19. store as-5 red blood cells between 1-6°c. 20. 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. 3 here cautions â¢the packet of ageless contained in this package absorbs oxygen and generates heat on removal and should be handled with care. ⢠dispose with packet in tray. ⢠do not dispose with wastes containing volatile or flammable materials. ⢠discard ageless packet without opening. terumo ® terumo corporation 44-1, 2-chome, hatagaya, shibuya-ku, tokyo, japan ®: registered trademark n-bb-op-a(sp) 3 image fig. 1 (attach luer adapter to tube holder) image figure sealing with tape image fig. 2 (attach adapter/holder to blood sampling arm)
Package Label Principal Display Panel:
Tray/case label teruflex® blood bag system with blood sampling arm® cpd with optisol® red cell preservative solution for collection of 500ml of blood each unit consists of a collection bag containing 70ml of anticoagulant cpd solution, with a satellite bag containing 111ml of optlsol red cell preservative solution. each 70ml anticoagulant cpd solution usp contains 1.79g dextrose (monohydrate) usp, 1.84g sodium citrate (dihydrate) usp, 209mg citric acid (anhydrous) usp, 156mg monobasic sodium phosphate (monohydrate) usp. each 111ml optisol red cell preservative solution contains 974mg sodium chloride usp, 1.00g dextrose (monohydrate) usp, 583mg mannitol usp, 33.3mg 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 blood sampling arm is a trademark of terumo corporation. rev. 01/03 b-4-h6-a4 2 place label here mage of representative tray/case label cpd-opt 500ml with bsa