AccessGUDID - DEVICE: CoolJect Targeted-Mist Topical Anesthetic (00860006961589)

GUDID

Device Identifier (DI) Information

Brand Name: CoolJect Targeted-Mist Topical Anesthetic
Version or Model: CJ02050-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vapocoolshot, Inc

Primary DI Number: 00860006961589
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 032313444 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLY	Vapocoolant Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193349	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 626c4617-2ee3-4433-b8a1-bf6c31eea3c6
Public Version Date: November 19, 2024
Public Version Number: 2
DI Record Publish Date: April 28, 2023