NAR Kit - KIT, NAR RESPONDER BALLISTIC VEST SYSTEM - RED w' - NORTH AMERICAN RESCUE, LLC

Duns Number:832426782

Device Description: KIT, NAR RESPONDER BALLISTIC VEST SYSTEM - RED w' YEL REFLECTIVE

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More Product Details

Catalog Number

80-1223

Brand Name

NAR Kit

Version/Model Number

80-1223

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"

-

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

f168b9d3-fe24-412c-8aa3-ac90fc687fb6

Public Version Date

April 12, 2022

Public Version Number

1

DI Record Publish Date

April 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORTH AMERICAN RESCUE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 23