AccessGUDID - DEVICE: Mojo Direct Action Bag

GUDID

Device Identifier (DI) Information

Brand Name: Mojo Direct Action Bag - Advanced
Version or Model: 01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 84-497
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68984497010
Issuing Agency: HIBCC
Commercial Distribution End Date: September 18, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: Equips trained medical first responders with a higher density of the core components identified by the CoTCCC as required to provide lifesaving interventions through buddy-aid and medical aid tasks during the Tactical Field Care phase of care. • The system is color coded and sequentially organized for rapid visual and muscle • memory identification of the appropriate tool required under the MARCH protocol. • The system has an “open architecture” which allows the introduction of emerging technologies that improve the lifesaving capabilities of the individual.

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?
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit With 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: 57cb5373-460a-4b6f-bad9-219c9c0de1b0
Public Version Date: April 12, 2022
Public Version Number: 4
DI Record Publish Date: September 22, 2017