Medi-First CPR Kit 8021B

GUDID 50347682802108

1 CPR Mask 1 Pair Nitrile Gloves 2 Benzalkonium Chloride 0.133% Wipes

Medique Products

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 50347682802108
• NIH Device Record Key: 29808f9a-5f19-454e-89fa-f8e3cf26eeec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medi-First CPR Kit
• Version Model Number: 8021B
• Catalog Number: 8021B
• Company DUNS: 086911794
• Company Name: Medique Products
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com
• Phone: 1-800-634-7680
• Email: cs@mediqueproducts.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00347682802103 [Primary]
GS1	50347682802108 [Package]; Contains: 00347682802103; Package: case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112126

FDA Product Code

• CBP: Valve, Non-Rebreathing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-28
• Device Publish Date: 2020-08-20

Devices Manufactured by Medique Products

• 50347682802108 - Medi-First CPR Kit: 2020-08-281 CPR Mask 1 Pair Nitrile Gloves 2 Benzalkonium Chloride 0.133% Wipes
• 50347682802108 - Medi-First CPR Kit: 2020-08-28 1 CPR Mask 1 Pair Nitrile Gloves 2 Benzalkonium Chloride 0.133% Wipes
• 50347682703245 - Medi-First 4-Shelf ANSI First Aid Cabinet: 2019-11-06 4-Shelf Kit Fill 1- Adhesive Bandage 1” x 3” Strip, 100/box 1- Adhesive Bandage, 7/8” x 3” Strip, 50/box 1- Adhesive Ban
• 50347682738247 - Medi-First 5-Shelf First Aid CabinetANSI: 2019-11-06 1 Adhesive Bandage 1” x 3” Strip, 100/box 1 Adhesive Bandage, 7/8” x 3” Strip, 50/box 1 Adhesive Bandage, 2” x 3” Pa
• 50347682739008 - Medi-First Plus Metal Large Trauma Kit: 2019-11-06 1- Adhesive Bandage, 7/8” x 3” Strip, 50/box 1- Adhesive Tape, Tri-Cut 5yd 1- Ammonia Inhalants, 10/box -1 Antiseptic Wipes,
• 50347682739015 - Medi-First Standard Trauma First Aid Kit: 2019-11-06 1- Adhesive Bandage, 7/8” x 3” Strip, 50/box 1- Adhesive Bandage, 2” x 3” Patch, 25/box 1- Adhesive Tape, Tri-Cut 5yd 1-
• 50347682740240 - Medi-First 25 Person Ansi First Aid Kit: 2019-11-06 16- Adhesive Bandage 1” x 3” Strip 8- Adhesive Bandage, Fingertip 8- Adhesive Bandage, Knuckle 1- Adhesive Tape, 1/2” x 2.
• 50347682740776 - Medi-First 25 Person Plastic First Aid Kit: 2019-11-06 16- Adhesive Bandage 1” x 3” Strip 8- Adhesive Bandage, Fingertip 8- Adhesive Bandage, Knuckle 1- Adhesive Tape, 1/2” x 2.
• 50347682745245 - Medi-First 3-Shelf Ansi First Aid Cabinet: 2019-11-06 1 Adhesive Bandage 1” x 3” Strip, 100/box 1 Adhesive Bandage, 7/8” x 3” Strip, 50/box 1 Adhesive Bandage, Fingertip, 40/