FDA.reportPublic FDA data

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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819601020013PackageGS112In Commercial Distribution
00819601020016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081960102001310819601020013
00819601020016008196010200168196010200160819601020016

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Weight1000Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-233-4334customerservice.healthcare@airliquide.com

Regulatory Flags#

DUNS number
831996595
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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00819601021235Scott Medical ProductsCalibration GasZ04OX46MSDC0022019-12-12
00819601025103Scott Medical ProductsAnesthesia Calibration GasZ04OX33KSD00002023-03-06
00819601024991Scott Medical ProductsAnesthesia Calibration GasZ02OX86MUD00002023-02-24
00819601025004Scott Medical ProductsAnesthesia Calibration GasZ03OX17MUD00002023-02-24
00819601025011Scott Medical ProductsAnesthesia Calibration GasZ03OX20MUD00012023-02-24
00819601025028Scott Medical ProductsAnesthesia Calibration GasZ03OX11MUD00012023-02-24
00819601025035Scott Medical ProductsAnesthesia Calibration GasZ03OX56MUD00002023-02-24
00819601025042Scott Medical ProductsCalibration GasZ02NI854SD00002023-02-24
00819601025059Scott Medical ProductsCalibration GasZ02NI804SD00002023-02-24
00819601025066Scott Medical ProductsCalibration GasZ03NI15415A00002023-02-24
00819601025073Scott Medical ProductsAnesthesia Calibration GasZ04NI70M15A00002023-02-25
00819601025080Scott Medical ProductsCalibration GasZ02NI83415A00012023-02-25
00819601025097Scott Medical ProductsCalibration GasZ02NI99415A00002023-02-25
00819601024960Bionostic, Inc.Calibration GasZ03NI85430000012023-02-17
00819601024977Bionostic, Inc.Calibration GasZ03NI82430000012023-02-17
00819601024984Bionostic, Inc.Calibration GasZ03NI874300Z2352023-02-17
00819601024922Scott Medical ProductsAnesthesia Calibration GasZ02OX96MUD00012023-02-13
00819601024939Scott Medical ProductsAnesthesia Calibration GasZ03OX24MUD00042023-02-13
00819601024946Scott Medical ProductsAnesthesia Calibration GasZ02AI82MUD00012023-02-13

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