Identity
- Trade Name
- EXCOR® FDA UDI
- Generic Name
- External ventricular circulatory assist system FDA UDI
- Device Name
- Accessory set PU valves EUDAMEDFDA UDI
- Model / Reference
- T00L-002 EUDAMEDFDA UDI
- Description
- Accessory set PU valves FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260090040553 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260090040553QE EUDAMED
- FDA Product Code
- DSQ FDA UDI
- EMDN Code
- C03010499 EXTRACORPOREAL CIRCULATION CANNULAS - OTHER EUDAMED
- GMDN Term
- External ventricular circulatory assist system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
MR Unsafe FDA UDI
Category: External ventricular circulatory assist system
Accessory set PU valves by Berlin Heart GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External ventricular circulatory assist system.
- Art. HLS cannula OD = 17 Fr (5.7 mm) 3/8" connector with LL, insertion length 23 cm — Maquet Cardiopulmonary GmbH · Class III
- EXCOR® — Berlin Heart, Inc. · Class III
- Art. HLS cannula OD = 15 Fr (5.0 mm) 3/8" connector with LL, insertion length 15 cm — Maquet Cardiopulmonary GmbH · Class IIa
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Venous HLS Cannula OD= 25Fr (8.3 mm) 3/8" connector without LL, insertion length 55 cm — Maquet Cardiopulmonary GmbH · Class IIa
- EXCOR® — Berlin Heart, Inc. · Class III
- Art. HLS cannula OD = 23 Fr (7.7 mm) 3/8" connector with LL, insertion length 23 cm — Maquet Cardiopulmonary GmbH · Class IIa
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4260090040553QE | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Berlin Heart GmbH
- EUDAMED SRN
- DE-MF-000006521
Sources (2)
- EUDAMED 82b2877d-b19f-4bc7-8b02-4bef6d4817eb 61 fields · synced Jun 18, 2026
- FDA UDI 82bf8df4-ed6a-4083-a17d-51b00b7c7f89 36 fields · synced May 30, 2026