Connecting set for cannulas and Cannula extension set
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- EXCOR® FDA UDI
- Generic Name
- External ventricular circulatory assist system FDA UDI
- Device Name
- Connecting set for cannulas and Cannula extension set EUDAMEDConnecting set for cannulas Ø 6/9 mm FDA UDI
- Model / Reference
- A06-009 EUDAMEDFDA UDI
- Description
- Connecting set for cannulas Ø 6/9 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260090040591 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260090042526QR 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 IIa EUDAMEDClass III FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 6 Millimeter FDA UDI
Category: External ventricular circulatory assist system
Connecting set for cannulas and Cannula extension set by Berlin Heart GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4260090042526QR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Berlin Heart GmbH
- EUDAMED SRN
- DE-MF-000006521
Sources (2)
- EUDAMED 14d851ca-0a38-4289-9046-a506d393a432 61 fields · synced Jul 20, 2026
- FDA UDI e7feff78-28e4-4b84-8def-da93dd5482f8 37 fields · synced May 30, 2026