Identity
- Trade Name
- AVID TruCustom FDA UDI
- Generic Name
- Cardiopulmonary bypass system, roller type FDA UDI
- Model / Reference
- SCRA001_0011 FDA UDI
Identifiers
- Catalog Number
- SCRA001 FDA UDI
- Primary DI / UDI-DI
- 10809160209493 FDA UDI
- FDA Product Code
- OEZ FDA UDI
- GMDN Term
- Cardiopulmonary bypass system, roller type FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
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: Cardiopulmonary bypass system, roller type
AVID TruCustom by Avid Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system, roller type.
- Variolock — LivaNova Deutschland GmbH · Class II
- Venous Line Clamp — LivaNova Deutschland GmbH · Class II
- HL 20 — Maquet Cardiopulmonary AG · Class II
- SCP — LivaNova Deutschland GmbH · Class II
- Accessories — LivaNova Deutschland GmbH · Class II
- ROTAFLOW — Maquet Cardiopulmonary AG · Class II
- S5 Roller Pump 150 — LivaNova Deutschland GmbH · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems 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
- Avid Medical, Inc.
Sources (1)
- FDA UDI ad0ebcfe-2249-4422-b51b-e47e0755d320 34 fields · synced May 29, 2026