AccessGUDID - DEVICE: NUM Vapocoolant (00850025535991)

GUDID

Device Identifier (DI) Information

Brand Name: NUM Vapocoolant
Version or Model: NS01B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gilero, LLC

Primary DI Number: 00850025535991
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 158233937 *Terms of Use

Device Description: NUM is a sterile topical anesthetic spray – vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries.

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:	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: less than 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 8.5 Gram

Device Record Status

Public Device Record Key: 3e5d8640-f76f-418e-8332-bc31513b3772
Public Version Date: June 14, 2021
Public Version Number: 1
DI Record Publish Date: June 04, 2021