H&H Civilian Cric Pack - One time use sterile emergency airway kit - H&H MEDICAL CORPORATION

Duns Number:072656713

Device Description: One time use sterile emergency airway kit

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More Product Details

Catalog Number

HHCCP01

Brand Name

H&H Civilian Cric Pack

Version/Model Number

Version 1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

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

246a2680-4a8e-455e-8ae1-75852426032b

Public Version Date

April 01, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"H&H MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 3