TMM-PPE, Advanced - Chinook designed TMM-PPE Kit, Advanced (Tactical - Chinook Medical Gear

Duns Number:621904622

Device Description: Chinook designed TMM-PPE Kit, Advanced (Tactical Medical Module-Personal Protective Equipm Chinook designed TMM-PPE Kit, Advanced (Tactical Medical Module-Personal Protective Equipment Kit, Advanced) with clothing and gear to provide barriers between you and a patient thus helping to prevent the spread of infection or illness. This kit contains the essential items necessary to protect your hands, clothes, face and lungs from splattered body fluids and airborne particles.

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More Product Details

Catalog Number

01457

Brand Name

TMM-PPE, Advanced

Version/Model Number

01457

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)

Yes

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

1afd06a9-edda-44e2-a355-7a38d6bd41bf

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

June 27, 2019

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