Identity
- Trade Name
- CANNULAE, SAPHENOUS VEIN FDA UDI
- Generic Name
- Cardioplegia cannula FDA UDI
- Device Name
- A sterile, single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device. FDA UDI
- Model / Reference
- 201006-000 FDA UDI
- Description
- A sterile, single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 201006-000 FDA UDI
- Primary DI / UDI-DI
- B0662010060000 FDA UDI
- 510(k) Number
- K801396 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardioplegia cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardioplegia cannula
Cannulae, Saphenous Vein by Novosci Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardioplegia cannula.
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- DLP™ — MEDTRONIC, INC. · Class II
- Cardioplegia cannula — LivaNova USA, Inc. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- Cardioplegia cannula — LivaNova USA, Inc. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- MICROTEK — Microtek Medical LLC · Class II
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
- Novosci Corp.
Sources (1)
- FDA UDI d8134eb5-0729-4840-8ceb-5eade3f15204 36 fields · synced May 30, 2026