AccessGUDID - DEVICE: 4" OLAES® HEMOSTATIC BANDAGE (00818630015369)

GUDID

Device Identifier (DI) Information

Brand Name: 4" OLAES® HEMOSTATIC BANDAGE
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 85-0020
Company Name: TACTICAL MEDICAL SOLUTIONS, LLC

Primary DI Number: 00818630015369
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131480662 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47011	First aid absorbent pad/bandage	A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHW	Dressing, Compression

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cd9e4029-a1ae-4734-a2cd-35111df02e58
Public Version Date: February 21, 2022
Public Version Number: 2
DI Record Publish Date: April 21, 2021