CoolJect Targeted-Mist Topical Anesthetic

GUDID 00860006961589

CoolJect Targeted-Mist Topical Anesthetic Canister with Integrated Nozzle (2 Wt. Oz). 1 Canister

Vapocoolshot, Inc

Cold/cool therapy spray

• Primary Device ID: 00860006961589
• NIH Device Record Key: 626c4617-2ee3-4433-b8a1-bf6c31eea3c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoolJect Targeted-Mist Topical Anesthetic
• Version Model Number: CJ02050-00
• Company DUNS: 032313444
• Company Name: Vapocoolshot, Inc
• 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: false
• Single Use: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com
• Phone: 1-833-266-5528
• Email: customerservice@vapocoolshot.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006961589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193349

FDA Product Code

• MLY: Vapocoolant Device

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: 2023-05-08
• Device Publish Date: 2023-04-28

On-Brand Devices [CoolJect Targeted-Mist Topical Anesthetic]

• 10860006961586: CoolJect Targeted-Mist Topical Anesthetic Canister with Integrated Nozzle (2 Wt. Oz). 12 Caniste
• 00860006961589: CoolJect Targeted-Mist Topical Anesthetic Canister with Integrated Nozzle (2 Wt. Oz). 1 Canister