Prescription drug · NDA
IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Blood NDC 53877-105
anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative · Kit · Terumo Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53877-105-06 | 53877010506 | 15 BLISTER PACK in 1 CASE (53877-105-06) / 1 BAG in 1 BLISTER PACK (53877-105-01) / 1 KIT in 1 BAG (53877-105-02) * 70 mL in 1 BAG (53877-111-70) * 111 mL in 1 BAG (53877-121-11)Marketed from Dec 15, 2010 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Generic name (nonproprietary)
- anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative
- Dosage form
- Kit
- Labeler
- Terumo CorporationNDC labeler code 53877
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication BN 880217
- Marketing start
- Listing expires
- Identifiers
- Product ID 53877-105_d1e10bfe-e386-4d21-9235-15ef3953e08fSPL ID d1e10bfe-e386-4d21-9235-15ef3953e08fSPL set ID ebaeef7d-abb9-4327-bb34-18d146a07376
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N453877010506followed by a unit qualifier and the quantityPackage 53877-0105-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE 1.1. Read these instructions carefully before use. 1.2. Rx ONLY. 1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion. 1.4. For the collection of 500 mL ±10% Whole Blood. 1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 1.6. Integral filter unit intended for leukocyte reduction of Whole Blood up to 8 hours after blood collection when Whole Blood is stored at ambient temperature. 1.7. For further processing, use standard component processing techniques.
Excerpt only. Read the full label for complete information.
About NDC 53877-105
- What is NDC 53877-105?
- 53877-105 is the product NDC for IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Blood kit, listed with the FDA by Terumo Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Blood (Anticoagulant Citrate Phosphate Dextrose (CPD) and AS-5 Red Cell Preservative).
- Who is the labeler?
- Terumo Corporation, NDC labeler code 53877. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Blood?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under BN 880217
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.