TACTICAL CricKIT - KIT, CRIC KIT - CUSTOM - NORTH AMERICAN RESCUE, LLC

Duns Number:832426782

Device Description: KIT, CRIC KIT - CUSTOM

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More Product Details

Catalog Number

85-2798

Brand Name

TACTICAL CricKIT

Version/Model Number

85-2798

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)

Yes

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

OGP

Product Code Name

Cricothyrotomy Kit

Device Record Status

Public Device Record Key

0558720e-cb93-49fe-ad2b-f650cd4e094e

Public Version Date

March 15, 2022

Public Version Number

2

DI Record Publish Date

December 09, 2019

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