Chinook BurnPAK - A compact, burn-injury personal aid kit. - Chinook Medical Gear

Duns Number:621904622

Device Description: A compact, burn-injury personal aid kit.

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More Product Details

Catalog Number

01402

Brand Name

Chinook BurnPAK

Version/Model Number

01402

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OHO

Product Code Name

First Aid Kit Without Drug

Device Record Status

Public Device Record Key

7e82a381-db85-4f10-8f98-12ce7cae2d7f

Public Version Date

May 22, 2020

Public Version Number

1

DI Record Publish Date

May 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHINOOK MEDICAL GEAR" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 274
2 A medical device with a moderate to high risk that requires special controls. 30