Identity
- Trade Name
- EXCOR® FDA UDI
- Generic Name
- External ventricular circulatory assist system FDA UDI
- Device Name
- Blood pump PU valves; 10 mL in/out; Ø 6 mm FDA UDI
- Model / Reference
- P10P-001 FDA UDI
- Description
- Blood pump PU valves; 10 mL in/out; Ø 6 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260090040102 FDA UDI
- FDA Product Code
- DSQ FDA UDI
- GMDN Term
- External ventricular circulatory assist system FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Category: External ventricular circulatory assist system
Excor® by Berlin Heart, Inc. — Class III — FDA UDI — listed in 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
- Art. HLS cannula OD = 15 Fr (5.0 mm) 3/8" connector with LL, insertion length 15 cm — Maquet Cardiopulmonary GmbH · Class IIa
- Driving tube — Berlin Heart GmbH · Class I
- 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
- 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
- Venous HLS Cannula OD= 21Fr (7.0 mm) 3/8" connector without LL, insertion length 38 cm — Maquet Cardiopulmonary GmbH · Class IIa
Cleared under the same submission
H100004 also covers:
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
P160035 also covers:
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
- EXCOR® — Berlin Heart, Inc.
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 |
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Manufacturer
- Manufacturer
- Berlin Heart, Inc.
Sources (1)
- FDA UDI b5d06d68-d97d-4b1d-a806-7b534f45486d 37 fields · synced Jun 8, 2026