Identity
- Trade Name
- Impella FDA UDI
- Generic Name
- Intracardiac circulatory assist axial-pump catheter FDA UDI
- Device Name
- Temporary cardiac support blood pump FDA UDI
- Model / Reference
- Impella CP Pump Set FDA UDI
- Description
- Temporary cardiac support blood pump FDA UDI
Identifiers
- Catalog Number
- 0048-0003.0814 FDA UDI
- Primary DI / UDI-DI
- 00813502011289 FDA UDI
- FDA Product Code
- OZD FDA UDI
- GMDN Term
- Intracardiac circulatory assist axial-pump catheter FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Impella by Abiomed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abiomed, Inc.
Sources (1)
- FDA UDI d89802eb-5ed2-4527-946f-c00ab16de0c9 36 fields · synced Jun 8, 2026