Duns Number:131480662
Device Description: The OLAES® Hemostatic Bandage combines the globally recognized OLAES® Modular Bandage with The OLAES® Hemostatic Bandage combines the globally recognized OLAES® Modular Bandage with battle tested HemCon® ChitoGauze® PRO to create the most comprehensive trauma bandage for multiple injury profiles. Both proven life-saving devices are now together in a single, easily accessible package to increase any level of pre-hospital care provider’s treatment capabilities while reducing application times and saving space in your kit.One of few CoTCCC recommended hemostatic dressings, ChitoGauze® PRO features chitosan as the hemostatic agent, is X-Ray detectable, and is located inside the bandage’s wound pad for rapid access at the point of injury. The included hemostatic gauze is located inside the bandage’s wound pad for rapid access at the point of injury.The convenience of having both products in a single kit item allows you to have more time to focus on treating your patient rather than locating and opening multiple packages. Its flat packed version easily fits into most standard IFAKs, giving you options to best fit your trauma kit space requirements.It was designed with direct input from some of the most experienced combat medics in the world, first responders here at home, and our end-users so no details are left out, making the OLAES® Hemostatic Bandage the best multi-functional piece of gear inside your kit.
Catalog Number
85-0024
Brand Name
4" FLAT PACKED OLAES® HEMOSTATIC BANDAGE
Version/Model Number
A
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"
-
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
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
27ff831f-2f72-4816-8f8b-af20eca11109
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
April 21, 2021
Package DI Number
00818630015512
Quantity per Package
100
Contains DI Package
00818630015505
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |