Thin H Compression Bandage, Standard Fold - Based on the proven design of the H-Bandage - H&H MEDICAL CORPORATION

Duns Number:072656713

Device Description: Based on the proven design of the H-Bandage compression dressing, the Thin H Bandage combi Based on the proven design of the H-Bandage compression dressing, the Thin H Bandage combines a 4" x 7.5" thick ABD pad with a strong elastic strap and the patented H-cleat compression device. The H-cleat allows first responders to deliver pressure down onto a wound to control bleeding and protect the wounded area.The H&H Thin H comes in a sterile, vacuum-sealed 5 mil barrier bag, in either a flat fold or a standard fold to create a small tight package. This gives users choices regarding which version to pack in their kit. The Thin H is popular in small kits, small vacuum-sealed packs, and as a stand-alone product.

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More Product Details

Catalog Number

HBT01

Brand Name

Thin H Compression Bandage, Standard Fold

Version/Model Number

1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

FQM

Product Code Name

Bandage, Elastic

Device Record Status

Public Device Record Key

19dc77ce-70b1-4ab6-9b34-cfbe9042211b

Public Version Date

July 20, 2020

Public Version Number

1

DI Record Publish Date

July 10, 2020

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