Catalog Number

-

Brand Name

Breathing bag 5.0L ISO

Version/Model Number

2165724

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 18, 2019

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BTC

Product Code Name

Bag, Reservoir

Public Device Record Key

264f8ade-63d6-428a-86ac-a1733df47b2e

Public Version Date

March 19, 2019

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-