First Aid Only - Bleeding Control Triage Kit Superior - Acme United Corporation

Duns Number:001180207

Device Description: Bleeding Control Triage Kit Superior

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More Product Details

Catalog Number

91107

Brand Name

First Aid Only

Version/Model Number

91107

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 31, 2023

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

-

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

af93c9e5-8e2e-4383-9ac8-b7b30b79a10b

Public Version Date

January 25, 2022

Public Version Number

1

DI Record Publish Date

January 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACME UNITED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 303