Identity
- Trade Name
- NAR FDA UDI
- Generic Name
- Blood donor set, single-pack FDA UDI
- Device Name
- KIT, FBTK DONOR MODULE FDA UDI
- Model / Reference
- 83-0001 FDA UDI
- Description
- KIT, FBTK DONOR MODULE FDA UDI
Identifiers
- Catalog Number
- 83-0001 FDA UDI
- Primary DI / UDI-DI
- 00842209103720 FDA UDI
- FDA Product Code
- POQ FDA UDI
- GMDN Term
- Blood donor set, single-pack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood donor set, single-pack
Nar by North American Rescue, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood donor set, single-pack.
- LCG2b with AS-1, AS-3 and AS-5 — MACO PHARMA · Class II
- Fresh Whole Blood Donor Transfusion Set — SAFEGUARD US OPERATING, LLC
- Fresh Whole Blood Donor Transfusion Set — SAFEGUARD US OPERATING, LLC · Class II
- Fresh Whole Blood Transfusion Set — SAFEGUARD US OPERATING, LLC · Class II
- Fresh Whole Blood Donor Transfusion Set — SAFEGUARD US OPERATING, LLC · Class II
- Haemonetics — HAEMONETICS CORPORATION · Class II
- VSL7001PD - Therapeutic Phlebotomy Bag w/Needle — MACO PHARMA · Class II
- VSL7000YD - Therapeutic Phlebotomy Bag — MACO PHARMA · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- North American Rescue, Llc.
Sources (1)
- FDA UDI 71744d61-6e6f-45a1-8a5d-9881d46bbbb9 34 fields · synced May 30, 2026