Duns Number:072656713
Device Description: The H-Bandage is the latest in Universal Severe Trauma Dressings. An upgrade to our patent The H-Bandage is the latest in Universal Severe Trauma Dressings. An upgrade to our patented combat dressing Cinch Tight, the H-Bandage gives medics and field personnel both an emergency dressing and a hemostat for arterial bleeding and hemorrhaging in limbs. The H-Bandage’s unique design allows for one-handed use under any condition. Designed for First Responders, Military, and Law Enforcement, the H-Bandage provides a fast, effective tool for all kinds of serious traumas and injuries involving arterial bleeding.The unique design of the H-Bandage, with its 8 in thick ABD pad and the unique 5 foot elastic wrap designed for both strength and flexibility along with the H-shaped cinch sewn into the bandage, allows it to satisfy multiple field needs. The H-shaped cinch allows for direct pressure to be applied directly on top of a wound, increasing compression and reducing blood loss.
Catalog Number
HB01
Brand Name
H-Bandage Compression Dressing - Rolled
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
b59ff45b-0cef-4c70-8f6c-fc936bf49e5d
Public Version Date
February 21, 2022
Public Version Number
2
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 |