Identity
- Trade Name
- Connector FDA UDI
- Generic Name
- Cardiopulmonary bypass system tubing connector FDA UDI
- Model / Reference
- AX-xxxxx FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803622106545 FDA UDI00803622103292 FDA UDI00803622106521 FDA UDI
- 510(k) Number
- K833322 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Cardiopulmonary bypass system tubing connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4290 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary bypass system tubing connector
Connector by LivaNova USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system tubing connector.
- Connector — LivaNova USA, Inc. · Class II
- Connector — LivaNova USA, Inc. · Class II
- Connector — LivaNova USA, Inc. · Class II
- Connector — LivaNova USA, Inc. · Class II
- Connector — LivaNova USA, Inc. · Class II
- Connector — LivaNova USA, Inc. · Class II
- Connector — LivaNova USA, Inc. · Class II
- Connector — LivaNova USA, Inc. · Class II
Cleared under the same submission
K833322 also covers:
- Assy, Venous Drainage, Cannula Conversion, 1/2 — LivaNova USA, Inc.
- Assy, Venous Drainage, Cannula Conversion, 3/8 — LivaNova USA, Inc.
- Cardiopulmonary bypass cannula vent plug — LivaNova USA, Inc.
- Connector — LivaNova USA, Inc.
- Connector — LivaNova USA, Inc.
- Connector — LivaNova USA, Inc.
- Connector — LivaNova USA, Inc.
- Connector — LivaNova USA, Inc.
- Connector — LivaNova USA, Inc.
- Connector — LivaNova USA, Inc.
- Connector — LivaNova USA, Inc.
- Connector — LivaNova USA, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (3)
- FDA UDI 40bcb4c9-dc2c-4cdb-812a-9a7af07b3817 33 fields · synced Jun 8, 2026
- FDA UDI 6a4c40fe-16c4-47ae-8a84-163a4d686777 33 fields · synced May 26, 2026
- FDA UDI 94c1ad6f-764d-476b-a53b-867c98f72060 33 fields · synced May 27, 2026