Identity
- Trade Name
- Global Blood Resources TS3 Sentara Tubing Set FDA UDI
- Generic Name
- Cardioplegia solution administration adaptor FDA UDI
- Model / Reference
- TS3-Sentara FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854438002026 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 TS3 Sentara Tubing Set 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
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- 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 53189d1f-d54d-4f0d-99a9-ada06c033d59 32 fields · synced Jun 6, 2026