Duns Number:072656713
Device Description: Our smallest and thinnest trauma compression bandage, the Mini Compression Bandage provide Our smallest and thinnest trauma compression bandage, the Mini Compression Bandage provides the same emergency trauma capabilities as our Thin H bandage in a smaller, more versatile package.Manufactured with a 4 in x 6 in ABD pad, it’s vacuum-sealed and flat folded to be small enough to fit in a shirt vest or pant pocket. With our 4-foot proprietary elastic strap (stretched, 34 inches unstretched), the Mini Compression Bandage is strong enough to provide compression to wounds on any location.
Catalog Number
HHMCB01
Brand Name
Mini Compression Bandage
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
50e4eca0-4376-41d8-9058-9a51656df912
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 |