Coolject Topical Anesthetic Canister

GUDID 00860006961503

Coolject Topical Anesthetic Canister

Vapocoolshot, Inc

Cold/cool therapy spray

• Primary Device ID: 00860006961503
• NIH Device Record Key: 5013d4a5-42d8-44b2-a8cf-0d9b0c4b021f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coolject Topical Anesthetic Canister
• Version Model Number: VM02000-00
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006961503 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-11-19
• Device Publish Date: 2023-01-27

On-Brand Devices [Coolject Topical Anesthetic Canister]

• 30860006961504: Coolject Topical Anesthetic Canister. 24 per box
• 10860006961500: Coolject Topical Anesthetic Canister. 12 per Box
• 20860006961507: Coolject Topical Anesthetic Canister. 3 per box
• 00860006961503: Coolject Topical Anesthetic Canister