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.
Catalog Number
HBTF
Brand Name
Thin H Compression Dressing, Flat Fold
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
c2bf2b0e-f5c9-45e8-9f20-244c9c081518
Public Version Date
July 20, 2020
Public Version Number
1
DI Record Publish Date
July 10, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |