Catalog Number

-

Brand Name

Filter

Version/Model Number

7-SP5125

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K922492,K922492

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

40373a6b-8c96-4f7d-89a9-d2e3aaa43c13

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

December 23, 2016

Package DI Number

10709078000994

Quantity per Package

50

Contains DI Package

00709078000997

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-