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510(k) Data Aggregation
K Number
K202782Device Name
num Vapocoolant
Manufacturer
623 Medical, LLC
Date Cleared
2020-12-21
(90 days)
Product Code
MLY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
623 Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
nüm 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 Description
num Vapocoolant is a sterile-fluid-path, single-use, prescription device that delivers a vapocoolant mixture of 95% r254fa (1,1,1,3,3-Pentafluoropropane) and 5% 134a (1,1,1,2-Tetrafluoroethane). The vapocoolant is stored in a sealed canister within the Main Body of the device. When dispensed from the canister, this mixture self-propels itself from the delivery system using its vapor pressure as propellant leaving the device exits through the Nozzle which is engineered to produce a mist spray. When the vapocoolant reaches the skin, cooling achieved through rapid evaporation of the non-medicated volatile products, and through the cooling capacity of the low-temperature evaporating vapocoolant. Device sterility is achieved through electron beam sterilization and maintained through protective Tyvek lidstock on the top of the nozzle, and a Cap in the base of the Main Body.
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