Prescription drug · NDA
TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood NDC 53877-103
Kit · Terumo Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53877-103-06 | 5387701030653877010306 | 6 BLISTER PACK in 1 CASE (53877-103-06) / 4 BAG in 1 BLISTER PACK (53877-103-01) / 1 KIT in 1 BAG (53877-103-02) * 70 mL in 1 BAG (53877-111-70) * 111 mL in 1 BAG (53877-121-11)Marketed from May 5, 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
- Brand name (proprietary)
- TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood
- Generic name (nonproprietary)
- dextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid, sodium phosphate, monobasic, unspecified form, anhydrous dextrose, sodium chloride, mannitol, and adenine
- 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 53877-103_5bc18ac1-9c3b-4005-bbf6-3b3ee0301f38SPL ID 5bc18ac1-9c3b-4005-bbf6-3b3ee0301f38SPL set ID 5b8b3dbb-b57b-4706-a7aa-daa173caffa2
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
N453877010306followed by a unit qualifier and the quantityPackage 53877-0103-06. 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 450 mL ±10% or 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. For further processing, use standard component processing techniques.
Excerpt only. Read the full label for complete information.
About NDC 53877-103
- What is NDC 53877-103?
- 53877-103 is the product NDC for TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution 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?
- TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood (Dextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, Sodium Phosphate, Monobasic, Unspecified Form, Anhydrous Dextrose, Sodium Chloride, Mannitol, and Adenine).
- 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 TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood?
- 1 other product NDC are listed under this name. See all TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1anhydrous citric acid, trisodium citrate dihydrate, sodium phosphate, monobasic, monohydrate, dextrose monohydrate, and adenine | Anhydrous citric acid 2.99 g/1000mL + 4 more ingredients | SolutionIntravenous | Terumo Corporation | 53877-110 | 53877-0110-06 |
Other NDCs under BN 880217
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.