Identity
- Trade Name
- Perfusion Pack FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Model / Reference
- Perfusion Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803622113925 FDA UDI
- GMDN Term
- Cardiopulmonary bypass system blood tubing set FDA UDI
Classification
- 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
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: Cardiopulmonary bypass system blood tubing set
Perfusion Pack by LivaNova USA, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system blood tubing set.
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- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (1)
- FDA UDI 403c30e9-ae64-4f5c-8d6b-85794f65fd50 32 fields · synced Jun 8, 2026