AccessGUDID - DEVICE: Medi-First Fanny Pack Basic Kit (00347682224738)

GUDID

Device Identifier (DI) Information

Brand Name: Medi-First Fanny Pack Basic Kit
Version or Model: 22473
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22473
Company Name: Medique Products

Primary DI Number: 00347682224738
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086911794 *Terms of Use

Device Description: 1 - Adhesive Bandage, 1” x 3” Strip, 16/box 2- Adhesive Bandage, 2” x 3” Patch 1 - Adhesive Tape, 1/2” x 5yd 1 - Ammonia Inhalants 6 - Antiseptic Wipes 2 - Burn Cream w/ Lidocaine, 0.9gm 1 - Cold Pack, Small 1 - CPR Mask/Breathing Barrier 1 - First Aid Handbook 3 - Gauze Pad 3” x 3” 5 - Insect Sting Relief Wipes 5 - Non-Aspirin Tablets, 2/pk 2 - Powder Free Exam Gloves, Disposable, Pair/L 1 - Scissors, 4.5” 1- Trauma Pad 5” x 9” 1 - Triangular Bandage with Pins, Non-Sterile 1 - Tweezers, Plastic, Disposable

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
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
Special Storage Condition, Specify: Sore at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 840ae11a-5f31-4391-a64f-5e911ac8c418
Public Version Date: August 01, 2019
Public Version Number: 1
DI Record Publish Date: July 24, 2019