Leukotrap Wb System - Cp2d
Cp2d/as-3 Anticoagulant And Additive System
Haemonetics Corporation
Human Prescription Drug
NDC 53157-126Leukotrap Wb System - Cp2d also known as Cp2d/as-3 Anticoagulant And Additive System is a human prescription drug labeled by 'Haemonetics Corporation'. National Drug Code (NDC) number for Leukotrap Wb System - Cp2d is 53157-126. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Leukotrap Wb System - Cp2d drug includes Dextrose - 3.57 g/70mL . The currest status of Leukotrap Wb System - Cp2d drug is Active.
Drug Information:
| Drug NDC: | 53157-126 |
| 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: | Leukotrap Wb System - Cp2d |
| 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: | Cp2d/as-3 Anticoagulant And Additive System |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Haemonetics Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | DEXTROSE - 3.57 g/70mL
|
| 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: | 07 Oct, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 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: | BN820915 |
| 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: | Haemonetics 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: | IY9XDZ35W2
JAC85A2161
|
| 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 |
|---|
| 53157-126-92 | 6 POUCH in 1 BOX (53157-126-92) / 3 BAG in 1 POUCH / 70 mL in 1 BAG | 07 Oct, 2015 | 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:
Leukotrap wb system - cp2d cp2d/as-3 anticoagulant and additive system citric acid monohydrate sodium citrate sodium phosphate, monobasic, monohydrate water dextrose dextrose leukotrap wb system - as3 cp2d/as-3 anticoagulant and additive system citric acid monohydrate sodium chloride sodium citrate sodium phosphate, monobasic, monohydrate water adenine adenine dextrose dextrose
Indications and Usage:
Indications and usage for collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction.
Warnings:
Warnings failure to achieve and maintain a closed system during processing would result in a product that must be transfused within 24 hours.
Description:
Description cp2d/as-3 blood bag unit with in-line wbf filter and sampling system instruction for use for systems containing a y sampling site (yss) or sample diversion pouch (with or without a pre-attached samp lok vacuum tube holder). refer to unit foil package label for specific product description being used. sterile, nonpyrogenic fluid path. sterilized by steam. rx only. this product is free of natural rubber latex.
How Supplied:
How supplied each shipping case contains 6 foil envelopes. within each foil envelope resides 3 clear pouches containing an individual collection system. each collection system consists of cp2d/as-3 500 ml, double blood bag collection system with sample diversion pouch.
Information for Patients:
Manufacturer manufactured for: haemonetics corporation 400 wood road braintree, ma 02184, usa by: haemonetics manufacturing inc 1630 industrial park street covina, ca 91722, usa visit us at www.haemonetics.com phone: 888.489.5938
Package Label Principal Display Panel:
Principal display panel cp2d 500 anticoagulant citrate phosphate double dextrose solution approx. 500 ml plus 70ml cp2d. store at 1â6 °c. 70 ml anticoagulant citrate phosphate double dextrose solution for collection of 500 ml of blood. each 70 ml of cp2d solution contains 3.57 g dextrose (monohydrate), usp; 1.84 g sodium citrate (dihydrate), usp; 0.229 g citric acid (monohydrate), usp; and 0.155 g monobasic sodium phosphate (monohydrate), usp. use only if solution is clear. see circular of information for indications, contraindications, cautions and methods of infusion. volunteer donor. this product may transmit infectious agents. rx only. properly identify intended recipient. cp2d 500 see circular of information for indications, contraindications, cautions and methods of infusion. volunteer donor. this product may transmit infectious agents. rx only. properly identify intended recipient. double 500ml cp2d/as-3 as-3 red blood cells adenine â saline added, leukocyte reduced 16.5 meq sodium added. from 500 ml cp2d whole blood. store at 1-6 o c. see circular of information for indications, contraindications, cautions and methods of infusion. volunteer donor this product may transmit infectious agents. rx only. properly identify intended recipient. leukotrap ® wb system cp2d/as-3 double blood bag unit with in-line wbf filter and sample diversion pouch for collection of 500 ml of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction each unit consists of a collection bag with 70 ml of cp2d solution, an additive bag with 110 ml of as-3 solution, and one empty bag. each 70 ml of cp2d solution contains 3.57 g dextrose (monohydrate), usp; 1.84 g sodium citrate (dihydrate), usp; 0.229 g citric acid (monohydrate), usp; and 0.155 g monobasic sodium phosphate (monohydrate), usp. each 110 ml of as-3 solution contains 1.21 g dextrose (monohydrate), usp; 0.647 g sodium citrate (dihydrate), usp; 0.451 g sodium chloride, usp; 0.304 g monobasic sodium phosphate (monohydrate), usp; 0.046 g citric acid (monohydrate), usp; and 0.033 g adenine, usp. sterile, nonpyrogenic fluid path. sterilized by steam. see accompanying directions for use. rx only. store at room temperature. unused bags in opened pouches may be kept 30 days by folding and securing open end of pouch to prevent possible loss of moisture. box label pouch label