AccessGUDID - DEVICE: Mojo First Responder Bag

GUDID

Device Identifier (DI) Information

Brand Name: Mojo First Responder Bag - Intermediate
Version or Model: 03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 83-303
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68983303030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: Your Mojo Medical Bag is equipped with MARCH Medical Gear featuring simple treatment icons and color-coding below: MASSIVE HEMORRAHAGE AIRWAY RESPIRATION CIRCULATION HEAD & HYPOTHERMIA

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: Yes 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: 3669ab67-0956-42c2-9eea-e826a4fba75b
Public Version Date: April 12, 2022
Public Version Number: 2
DI Record Publish Date: July 30, 2018