Catalog Number

-

Brand Name

Maxi-Pleat

Version/Model Number

6888/20BAUA001/0001

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"

-

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

K033008,K033008

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

d137a2d8-47e8-4a9d-aca8-932a852999f7

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

25060120952565

Quantity per Package

50

Contains DI Package

15060120952568

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box