First Aid Only - Personal First Aid Kit containing supplies for a - Acme United Corporation

Duns Number:001180207

Device Description: Personal First Aid Kit containing supplies for a minor injury.

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More Product Details

Catalog Number

38000-002

Brand Name

First Aid Only

Version/Model Number

38000

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRR

Product Code Name

First Aid Kit With Drug

Device Record Status

Public Device Record Key

3a48afef-2ee9-4c5e-9fd2-de377b8772a9

Public Version Date

April 15, 2021

Public Version Number

2

DI Record Publish Date

December 14, 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