Catalog Number

MC-125

Brand Name

Infant Bacterial/Viral Filter

Version/Model Number

MC-125

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K851070,K851070

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

b7710bf9-69ca-4391-bf90-f591d156ca3b

Public Version Date

October 21, 2020

Public Version Number

6

DI Record Publish Date

September 11, 2017

Package DI Number

10858409005013

Quantity per Package

50

Contains DI Package

00858409005016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case