Catalog Number

-

Brand Name

Breath syst 10mm HME Disp1.2m

Version/Model Number

6694105

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

3f3c23ef-1ba1-4548-804d-308f468e913c

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

October 30, 2015

Package DI Number

17325710002428

Quantity per Package

20

Contains DI Package

07325710002421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-