Catalog Number

-

Brand Name

Breathing Bag

Version/Model Number

S6569P

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

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

BTC

Product Code Name

Bag, Reservoir

Public Device Record Key

f6b7892a-08d8-436a-ab9a-fd94228a0861

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

October 30, 2020

Package DI Number

10709078011723

Quantity per Package

50

Contains DI Package

00709078011726

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case