FDA.reportPublic FDA data

NUM Vapocoolant

Primary DI
00850025535991
Brand
NUM Vapocoolant
Company
Gilero, LLC
Model
NS01B
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.
Published
2021-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLYVapocoolant Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLYVapocoolant DeviceUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850025535998PackageGS12In Commercial Distribution
00850025535991PrimaryGS10
00850025535984Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002553599810850025535998
00850025535991008500255359918500255359910850025535991
00850025535984008500255359848500255359840850025535984

GMDN Terms#

Term, Definition table
TermDefinition
Cold/cool therapy sprayA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight8.5Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(877) 455-0112info@623medical.com

Regulatory Flags#

DUNS number
158233937
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382902002505BD SmartSite Bag 250mL11365-325-192002502023-12-01
00382902005001BD SmartSite Bag 500mL11365-325-042005002023-12-01
00382902001003BD SmartSite Bag 100mL11365-325-182001002023-12-01
50382902002500BD SmartSite Bag 250mL11365-325-192002502023-12-01
50382902005006BD SmartSite Bag 500mL11365-325-042005002023-12-01
00850025535502UTC 3ml Medication Cartridge11949-325-0911949-325-092023-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10723797170615InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170721InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170837InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170943InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
00850079280298HexaHexa DentalMLY2026-01-21
10723797806446Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797807443Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797809447Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797806443Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797807440Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797808440Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797809444Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
00860010587355DentalJect ApplicatorVapocoolshot, IncMLY2025-11-07
00860010587362DentalJect Syringe ConnectorVapocoolshot, IncMLY2025-11-07
00860010587393DentalJect Starter Kit - No Syringe ConnectorVapocoolshot, IncMLY2025-11-07
00860010587348DentalJect CanisterVapocoolshot, IncMLY2025-09-08
00860010587379DentalJect Applicator SetVapocoolshot, IncMLY2025-09-08
00860010587386DentalJect Starter KitVapocoolshot, IncMLY2025-09-08
00860010587331CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncMLY2025-08-01
00860010587324CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
10860010587321CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
00860006961596CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
00860006961589CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
10860006961586CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
10860006961524Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
20860006961521Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961527Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961503Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncMLY2023-01-27