Medi-First Deluxe Plastic Burn Kit

Basic Information

• Brand Name: Medi-First Deluxe Plastic Burn Kit
• Primary DI: 00347682896119
• Version / Model: 89611
• Catalog Number: 89611
• Company Name: Medique Products
• Labeler DUNS: 086911794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-19
• Public Version: 2
• Public Version Date: 2019-09-10
• Public Version Status: Update
• Public Device Record Key: fba91e1c-74fd-489d-808f-182aa8ed719c

Device Description

1- Antiseptic Wipes, 10ct 1 -1” x 3” Plastic Strips, 16ct 2 -4" x 4" Burn Dressings 2 -2" x 6" Burn Dressings 1 -4” x 16” Burn Dressing 6 -Water Jel Burn Jel 3.5gm Pkts 1 -Derma Cool, 2oz Bottle 2 -Vinyl Exam Gloves, pr 2 -2” Stretch Roller Gauze 1 -2” Elastic Wrap w/ Clips 1 -1/2” x 5yds Adhesive Tape 1 -Scissors, 4.5” 6 -Gauze Pads 2” x 2” 6 -Gauze Pads 3” x 3” 1 -Instruction Sheet

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJI	Burn Kit With Drug	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
10516	Burn kit, non-medicated	A collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50347682896114	GS1	master case	10	In Commercial Distribution
Primary	00347682896119	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature