FILTER, GAS/OXYGEN - A sterile, porous device used in the arterial - NOVOSCI CORP.

Duns Number:938289980

Device Description: A sterile, porous device used in the arterial line of an extracorporeal circuit, during a 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.

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More Product Details

Catalog Number

301001-000

Brand Name

FILTER, GAS/OXYGEN

Version/Model Number

301001-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KRI

Product Code Name

Accessory Equipment, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

f27bdd6a-2497-4aa1-aad4-6d91daee8399

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2015

Additional Identifiers

Package DI Number

B0663010010005

Quantity per Package

40

Contains DI Package

B0663010010000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"NOVOSCI CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 50