NUM Vapocoolant

Basic Information

• Brand Name: NUM Vapocoolant
• Primary DI: 00850025535991
• Version / Model: NS01B
• Company Name: Gilero, LLC
• Labeler DUNS: 158233937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2021-06-04
• Public Version: 1
• Public Version Date: 2021-06-14
• Public Version Status: New
• Public Device Record Key: 3e5d8640-f76f-418e-8332-bc31513b3772

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

• Single Use: Yes
• 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: Yes
• 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	00850025535991	GS1
Package	10850025535998	GS1		2	In Commercial Distribution
Unit of Use	00850025535984	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	8.5	Gram

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 60 Degrees Celsius