AccessGUDID - DEVICE: Mojo Multi Mission Bag

GUDID

Device Identifier (DI) Information

Brand Name: Mojo Multi Mission Bag - Basic
Version or Model: 11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 84-441
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68984441110
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: The Mojo® Multi-Mission Aid Bag is two medic bags in one. A main bag with 2,645 in3 of interior space designed and stocked to carry component resupply or to provide sustainment of multiple casualties for extended periods. The kit also includes a zip-off, low profile assault bag with 595 in3 of interior space that is configured and stocked for trauma and immediate tactical care. Assault, tactical or sustained care, together these two bags provide the Medic multiple options for every possible mission.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
44047	First aid kit, non-medicated, single-use	A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHO	First Aid Kit Without Drug

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: 52451033-f291-4fb0-8b0f-b426c6a6c94c
Public Version Date: April 11, 2025
Public Version Number: 1
DI Record Publish Date: April 03, 2025