AccessGUDID - DEVICE: Medi-First 16 Unit Metal First Aid Kit (00347682168629)

GUDID

Device Identifier (DI) Information

Brand Name: Medi-First 16 Unit Metal First Aid Kit
Version or Model: 16UMA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16UMA
Company Name: Medique Products

Primary DI Number: 00347682168629
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086911794 *Terms of Use

Device Description: 17378 - 0.006 M Hand Sanitizer Bulk 20669 - 1 EACH Burn Cream w/Lidocaine Unit (1 21412 - STD 2 EACH Antiseptic Towelettes 5X7 10s 22312 – 2 EACH Triple Antibiotic Ointment 10c 3060 - 1 EACH BurnAid Dress4x4 60075 – 4 EACH 1"X3" Plastic Strip 16s 61270 – 3 EACH 3"X3" Sterile Gauze Pads 4 62730 – 1 EACH Woven Knuckle 8s 63775 – 2 EACH 3/4"x3" Plastic Strip 16 6501B – 2 EACH Triangular Band W/Pins 40" 68999 – 1 EACH 2" Stretch Roller Gauze Unit 71401 – 1 EACH FIRST AID HANDBOOK 72401 - 1 EACH Ice Pack small/boxed EACH 73699 – 1 EACH Disposable Nitrile Gloves 2s Unit 7371B - 1 EACH Forceps and Scissor Unit 77901 - STD 1 EACH Eye Unit (eyewash, tape, pad) 80201 – 1 EACH CPR Mask 89801 - 2 EACH ABD Sterile 5x9 1s

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: Store at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d04c4acd-86ce-4965-b052-c23b4b281797
Public Version Date: August 01, 2019
Public Version Number: 1
DI Record Publish Date: July 24, 2019