NUM Vapocoolant

GUDID 00850025535991

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.

Gilero, LLC

Cold/cool therapy spray
Primary Device ID00850025535991
NIH Device Record Key3e5d8640-f76f-418e-8332-bc31513b3772
Commercial Distribution StatusIn Commercial Distribution
Brand NameNUM Vapocoolant
Version Model NumberNS01B
Company DUNS158233937
Company NameGilero, LLC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com
Phone(877) 455-0112
Emailinfo@623medical.com

Device Dimensions

Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram
Weight8.5 Gram

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850025535984 [Unit of Use]
GS100850025535991 [Primary]
GS110850025535998 [Package]
Package: [2 Units]
In Commercial Distribution

FDA Product Code

MLYVapocoolant Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-14
Device Publish Date2021-06-04

Devices Manufactured by Gilero, LLC

00382902001003 - BD SmartSite Bag 100mL2023-12-11 The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular a
50382902002500 - BD SmartSite Bag 250mL2023-12-11 The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular a
50382902005006 - BD SmartSite Bag 500mL2023-12-11 The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular a
00850025535502 - UTC 3ml Medication Cartridge2023-10-03 UTC 3mL Medication Cartridge: The UTC 3 mL Medication Cartridge is intended for use in hospital and outpatient care environments
00850025535991 - NUM Vapocoolant2021-06-14NUM 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.
00850025535991 - NUM Vapocoolant2021-06-14 NUM is a sterile topical anesthetic spray – vapocoolant (skin refrigerant) intended for topical application to control pain as

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.