Catalog Number

K616-002

Brand Name

OTS - Class B Field Trauma - Hawkes Bag

Version/Model Number

K616-002

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K940249,K940333,K940336,K940345,K940358,K945002,K945004,K960587,K960615

Product Code

CBP

Product Code Name

Valve, non-rebreathing

Public Device Record Key

073eeafe-0f1a-45f7-993a-2b3fced926d6

Public Version Date

February 21, 2022

Public Version Number

6

DI Record Publish Date

November 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-