FDA.reportPublic FDA data

CoolJect Targeted-Mist Topical Anesthetic

Primary DI
00860010587331
Brand
CoolJect Targeted-Mist Topical Anesthetic
Company
Vapocoolshot, Inc
Model
CJ04050-12
Catalog number
CJ04050-12
Device description
CoolJect Targeted-Mist Topical Anesthetic Canister with Integrated Nozzle (4 Wt. Oz). 12 Canisters per box.
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MLYVapocoolant Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLYVapocoolant DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193349000Vapocoolshot MistVapocoolshot, Inc.2020-04-14MLY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010587331PrimaryGS10
10860010587321Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010587331008600105873318600105873310860010587331
1086001058732110860010587321

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.

Regulatory Flags#

DUNS number
032313444
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010587355DentalJect ApplicatorDJ01000-00DJ01000-002025-11-07
00860010587362DentalJect Syringe ConnectorDJ02000-00DJ02000-002025-11-07
00860010587393DentalJect Starter Kit - No Syringe ConnectorDJ06000-00DJ06000-002025-11-07
10860006961524Coolject Topical Anesthetic CanisterVM02000-122023-01-27
20860006961521Coolject Topical Anesthetic CanisterVM02000-242023-01-27
00860006961527Coolject Topical Anesthetic CanisterVM02000-032023-01-27
00860006961503Coolject Topical Anesthetic CanisterVM02000-002023-01-27
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVM01000-002023-01-27
00860006961534Coolject 1-3cc Syringe Holder Nozzle AccessoryVM01000-002023-01-27
00860006961541Coolject Standard Nozzle AccessoryVM01100-002023-01-27
00860006961558Coolject Standard Nozzle AccessoryVM01100-002023-01-27
00860010587348DentalJect CanisterDJ03000-012025-09-08
00860010587379DentalJect Applicator SetDJ04000-002025-09-08
00860010587386DentalJect Starter KitDJ05000-002025-09-08
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryCJ01050-00CJ01050-002025-08-01
00860010587324CoolJect Targeted-Mist Topical AnestheticCJ04050-00CJ04050-002025-08-01
10860010587321CoolJect Targeted-Mist Topical AnestheticCJ04050-12CJ04050-122025-08-01
00860006961596CoolJect Targeted-Mist Topical AnestheticCJ02050-122023-04-28
20860006961507Coolject Topical Anesthetic CanisterVM02000-032023-01-27
10860006961500Coolject Topical Anesthetic CanisterVM02000-122023-01-27

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
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
20860006961507Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27