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Line, Arterial Filter Purge

FDA UDI

Class II (US FDA UDI)

by Novosci Corp.

Identity

Trade Name
LINE, ARTERIAL FILTER PURGE 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
201008-000 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
201008-000 FDA UDI
Primary DI / UDI-DI
B0662010080000 FDA UDI
510(k) Number
K820472 FDA UDI
FDA Product Code
DTM FDA UDI
GMDN Term
Cardiopulmonary bypass system filter, arterial blood line FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4260 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

Yes

FDA UDI

Category: Cardiopulmonary bypass system filter, arterial blood line

Line, Arterial Filter Purge by Novosci Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system filter, arterial blood line.

Cleared under the same submission

K820472 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novosci Corp.

Sources (1)

  • FDA UDI 754ef161-7a3d-48db-a79e-74c688a145d8 36 fields · synced Jun 1, 2026