Catalog Number

-

Brand Name

Gamow Bag

Version/Model Number

15C37199

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

-

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

K001409,K001409,K001409,K001409

Product Code

CBF

Product Code Name

Chamber, Hyperbaric

Public Device Record Key

b5bf7282-4b5d-4859-86e3-347b99db0458

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 22, 2016

Package DI Number

10856039006523

Quantity per Package

2

Contains DI Package

10856039006516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-