FDA.report

OriginAL Pure Cryogen

Primary DI
00819601020016
Brand
OriginAL Pure Cryogen
Company
AIRGAS USA LLC
Model
RLMDGPD12C840
Catalog number
RLMDGPD12C840
Device description
R-134a in a canister for use in a Candela laser system. The gas is used for reduction of pain by cooling of skin prior to treatment with a Candela laser system.
Published
2017-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10819601020013PackageGS112In Commercial Distribution
00819601020016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081960102001310819601020013
00819601020016008196010200168196010200160819601020016

GMDN Terms

TermDefinition
Freon cartridgeA device in the shape of a small sealed cylinder, containing pressurized Freon gas, intended to be inserted into a parent device where it is perforated so that its gas content can serve a specific function (e.g., a source of power or a refrigerant). The effect of the gas has a direct impact upon the functional use of the parent medical device (e.g., an antishock unit, a tourniquet unit, or a cryo-unit). The cartridge is discarded when it is empty of Freon gas.

Device Sizes

TypeValueUnit
Weight1000Gram

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-233-4334customerservice.healthcare@airliquide.com

Regulatory Flags

DUNS number
831996595
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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