Identity
- Trade Name
- Global Blood Resources FDA UDI
- Generic Name
- Cardioplegia solution administration adaptor FDA UDI
- Device Name
- Tubing Set FDA UDI
- Model / Reference
- TS3 FDA UDI
- Description
- Tubing Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854438002019 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardioplegia solution administration adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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: Cardioplegia solution administration adaptor
Global Blood Resources by Global Blood Resources, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Cardioplegia solution administration adaptor — LivaNova USA, Inc. · Class II
- Terumo Cardiovascular Systems — MED MICHIGAN HOLDINGS LLC · Class II
- DLP® — MEDTRONIC, INC. · Class II
- PERFUSION ADAPTER SET — NOVOSCI CORP. · 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
- Global Blood Resources, Llc
Sources (1)
- FDA UDI e7837b2c-273c-4da3-9c7e-8d7f01c8b14b 34 fields · synced May 30, 2026