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Connector Cable
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0042-0002, 0042-0012
by Abiomed Inc.
Identity
- Trade Name
- Impella FDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- Connector Cable EUDAMEDSterile Connector Cable Pump / IMC FDA UDI
- Model / Reference
- 0042-0002, 0042-0012 EUDAMED0042-0002 FDA UDI
- Description
- Sterile Connector Cable Pump / IMC FDA UDI
Identifiers
- Catalog Number
- 0042-0002 FDA UDI
- Primary DI / UDI-DI
- 04260113630259 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260113630259 EUDAMED
- FDA Product Code
- OZD FDA UDIPYX FDA UDI
- EMDN Code
- C9080 CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Regulation Number
- 870.4360 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Connector Cable by Abiomed, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260113630259 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Abiomed Inc.
- EUDAMED SRN
- US-MF-000016855
- Authorised Representative
- Abiomed Europe GmbH DE-AR-000005280
Sources (3)
- EUDAMED 13a1d460-e1f3-479a-b371-1cd258eb7377 61 fields · synced Jul 31, 2026
- FDA UDI 5b03aaec-5430-49db-9ef5-fa468945fc50 35 fields · synced May 29, 2026
- EUDAMED 13a1d460-e1f3-479a-b371-1cd258eb7377-1 61 fields · synced Jun 10, 2026