Catalog Number

-

Brand Name

Breath syst 10mm HME & MR 3M Disp

Version/Model Number

6694145

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Public Device Record Key

9d8065ba-3421-4fe2-ac2a-2db290a1104b

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

October 30, 2015

Package DI Number

17325710002336

Quantity per Package

20

Contains DI Package

07325710002339

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-