CoolJect Targeted-Mist Topical Anesthetic

Basic Information

• Brand Name: CoolJect Targeted-Mist Topical Anesthetic
• Primary DI: 00860006961589
• Version / Model: CJ02050-00
• Company Name: Vapocoolshot, Inc
• Labeler DUNS: 032313444
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-28
• Public Version: 1
• Public Version Date: 2023-05-08
• Public Version Status: New
• Public Device Record Key: 626c4617-2ee3-4433-b8a1-bf6c31eea3c6

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• 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: No
• 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
MLY	Vapocoolant Device	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46557	Cold/cool therapy spray	A non-sterile liquid (e.g., alcohol based) in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling typically from sports injuries (cold therapy), and/or for cooling at the skin surface to treat heat rash or hot flushes (cool therapy); it may be intended to be applied to the skin directly or used in combination with a moist-cold pack/bandage (i.e., used to soak the moist-cold pack/bandage). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860006961589	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193349	000