4" OLAES® HEMOSTATIC BANDAGE

Basic Information

• Brand Name: 4" OLAES® HEMOSTATIC BANDAGE
• Primary DI: 00818630015369
• Version / Model: A
• Catalog Number: 85-0020
• Company Name: TACTICAL MEDICAL SOLUTIONS, LLC
• Labeler DUNS: 131480662
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-21
• Public Version: 2
• Public Version Date: 2022-02-21
• Public Version Status: Update
• Public Device Record Key: cd9e4029-a1ae-4734-a2cd-35111df02e58

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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "Radiation Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MHW	Dressing, Compression	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818630015369	GS1
Package	10818630015366	GS1	BOX	100	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]