Identity
- Trade Name
- FILTER, GAS/OXYGEN FDA UDI
- Generic Name
- Cardiopulmonary bypass system filter, arterial blood line FDA UDI
- Device Name
- A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device. FDA UDI
- Model / Reference
- 301001-000 FDA UDI
- Description
- A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 301001-000 FDA UDI
- Primary DI / UDI-DI
- B0663010010000 FDA UDI
- FDA Product Code
- KRI FDA UDI
- GMDN Term
- Cardiopulmonary bypass system filter, arterial blood line FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4200 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary bypass system filter, arterial blood line
Filter, Gas/Oxygen by Novosci Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system filter, arterial blood line.
- KIDS — SORIN GROUP ITALIA SRL · Class II
- Pall LeukoGuard LG — Pall International SARL · Class II
- Capiox® Arterial Filter — Terumo Cardiovascular Systems Corporation · Class II
- Affinity™ — MEDTRONIC, INC. · Class II
- Affinity Pixie™ — MEDTRONIC, INC. · Class II
- MICRO — SORIN GROUP ITALIA SRL · Class II
- AFFINITY® — MEDTRONIC, INC. · Class II
- Affinity™ — MEDTRONIC, INC. · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novosci Corp.
Sources (1)
- FDA UDI f27bdd6a-2497-4aa1-aad4-6d91daee8399 35 fields · synced May 30, 2026