First Aid Only - Custom first aid kit containing first aid items - Acme United Corporation

Duns Number:001180207

Device Description: Custom first aid kit containing first aid items needed to help treat minor injuries.

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More Product Details

Catalog Number

5436

Brand Name

First Aid Only

Version/Model Number

5436

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

-

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

d29cedf1-153c-4011-b6b0-c51774d2b5d6

Public Version Date

April 15, 2021

Public Version Number

2

DI Record Publish Date

December 12, 2020

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