First Aid Only - First Aid Bleeding Control Cabinet - Basic Pro - Acme United Corporation

Duns Number:001180207

Device Description: First Aid Bleeding Control Cabinet - Basic Pro Kit contains: Four Fabric Zippered Pouches First Aid Bleeding Control Cabinet - Basic Pro Kit contains: Four Fabric Zippered Pouches, each containing: Windlass Tourniquet; Back-up Elastic Tourniquet; Aluminized Rescue/Shock Blanket; Trauma Pad Dressing, 5"x9"; 2 pairs of Protective Nitrile Exam Gloves; pair of Bandage Shears; Marker; Bleeding Control Product Usage Guidelines

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More Product Details

Catalog Number

91189

Brand Name

First Aid Only

Version/Model Number

91189

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

4661354c-3571-4749-8271-59883d90f0b4

Public Version Date

July 07, 2021

Public Version Number

2

DI Record Publish Date

May 25, 2021

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