AccessGUDID - DEVICE: Mojo Bleeder Holster Kit (M6898811503010)

GUDID

Device Identifier (DI) Information

Brand Name: Mojo Bleeder Holster Kit
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88-115-03
Company Name: Safeguard US Operating, LLC

Primary DI Number: M6898811503010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: This kit treats Massive Hemorrhage and comes in nylon holster style belt pouch. The kit contains Celox Rapid hemostatic gauze, and tourniquet of choice and exam gloves. The pouch has a vertical belt loop and can be worn on your standard 2” wide utility and gun belts.

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:	Yes
Combination Product:	Yes
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?
62004	Wound dressing kit, medicated, non-sterile	A collection of non-sterile instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug
GAX	Tourniquet, Nonpneumatic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: b3be947c-867e-42b3-88c6-5437c20c17ff
Public Version Date: April 12, 2022
Public Version Number: 2
DI Record Publish Date: March 16, 2018