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OriginAL Pure Cryogen

FDA UDI

Class II (US FDA UDI)

by Airgas Usa Llc

Identity

Trade Name
OriginAL Pure Cryogen FDA UDI
Generic Name
Freon gas cartridge FDA UDI
Device Name
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. FDA UDI
Model / Reference
RLMDGPD12C840 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
RLMDGPD12C840 FDA UDI
Primary DI / UDI-DI
00819601020016 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Freon gas cartridge FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Weight — 1000 Gram FDA UDI

Category: Freon gas cartridge

OriginAL Pure Cryogen by Airgas Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Freon gas cartridge.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Airgas Usa Llc

Sources (1)

  • FDA UDI a8d024f6-4d1f-442e-85c0-f59dfc9bfb8a 37 fields · synced Jun 1, 2026