Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Blood transfusion set, non-exchange FDA UDI
- Device Name
- Curaplex BTM Field Blood Administration Kit FDA UDI
- Model / Reference
- 670183-KIT FDA UDI
- Description
- Curaplex BTM Field Blood Administration Kit FDA UDI
Identifiers
- Catalog Number
- 670183-KIT FDA UDI
- Primary DI / UDI-DI
- 00812277035254 FDA UDI
- FDA Product Code
- POQ FDA UDI
- GMDN Term
- Blood transfusion set, non-exchange 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
Yes
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 transfusion set, non-exchange
Curaplex by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood transfusion set, non-exchange.
- Blood Administration Set — Merit Pharmaceutical · Class II
- Walrus — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · Class II
- Blood Administration Set — B. BRAUN MEDICAL INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- CLEARLINK — BAXTER INTERNATIONAL INC. · Class II
- CODAN — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · 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 |
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Manufacturer
- Manufacturer
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI 89270145-931b-4c17-87ea-f19a0bfcd7b1 34 fields · synced May 31, 2026