Identity
- Trade Name
- Bio-Medicus Life Support™ FDA UDI
- Generic Name
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI
- Device Name
- CATHETER LS96010-013 BIO-MED ART 13FR FDA UDI
- Model / Reference
- LS96010-013 FDA UDI
- Description
- CATHETER LS96010-013 BIO-MED ART 13FR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000615352 FDA UDI
- FDA Product Code
- QHW FDA UDI
- GMDN Term
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4100 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Length — 11.0 Centimeter FDA UDICatheter Gauge — 13.0 French FDA UDI
Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Bio-Medicus Life Support™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return.
- AESCULAP — AESCULAP, INC. · Class I
- PureFlex Arterial Cannulae — SORIN GROUP ITALIA SRL · Class II
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- PureFlex Arterial Cannulae — SORIN GROUP ITALIA SRL · Class II
- Paediatric Arterial Cannula — SORIN GROUP ITALIA SRL · Class II
- Edwards Lifesciences EZ Glide Aortic Cannula — Edwards Lifesciences LLC · Class II
Cleared under the same submission
K201057 also covers:
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
K201100 also covers:
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, INC.
- Bio-Medicus Life Support™ — MEDTRONIC, 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 |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 03b6b8b4-5156-4c12-8c4b-31047e52e7d1 37 fields · synced Jun 8, 2026