Catalog Number

-

Brand Name

n.a.

Version/Model Number

88-11-000

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

-

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

BYW

Product Code Name

Device, Rebreathing

Public Device Record Key

1d0292c1-8343-47ca-835f-7d049dfcd12b

Public Version Date

September 12, 2022

Public Version Number

2

DI Record Publish Date

August 25, 2020

Package DI Number

24250105628504

Quantity per Package

10

Contains DI Package

14250105628507

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-