AccessGUDID - DEVICE: Medi-First 50 Person Class B Plastic First Aid Kit (00347682787240)

GUDID

Device Identifier (DI) Information

Brand Name: Medi-First 50 Person Class B Plastic First Aid Kit
Version or Model: 787ANSI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 787ANSI
Company Name: Medique Products

Primary DI Number: 00347682787240
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, 100/box 1 Adhesive Tape, 1/2” x 5yd 1 Antiseptic Spray 2oz Pump 2 Burn Dressing 4” x 4” 1 Burn Spray 2oz Pump 2 Cold Pack, Small, Boxed 1 CPR Mask/Breathing Barrier 4 Eye Pads 1 Eyewash 4oz 1 First Aid Handbook 4 Gauze Pad 3” x 3”, Sterile 2 Gauze Roll 2” x 5yds 1 Gauze Roll 4” x 5yds 1 Hand Sanitizer, 10/bag 4 Powder Free Exam Gloves, Disposable, Pair/L 1 Scissors 4.5” 1 Splint, Multi-Purpose 1 Tourniquet 4 Trauma Pads 5” x 9” 2 Triangular Bandage with Pins, Non-Sterile 1 Triple Antibiotic Ointment, 25/box 1 ANSI Sticker

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: 44ed48ae-a152-467d-a6ba-a3f6c67a7731
Public Version Date: August 01, 2019
Public Version Number: 1
DI Record Publish Date: July 24, 2019