Identity
- Trade Name
- Applied Medical Laser FDA UDI
- Generic Name
- Freon gas cartridge FDA UDI
- Device Name
- Description: H-134a; Cylinder: PD; Valve: CGA 600; 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
- Skin Cooling FDA UDI
- Description
- Description: H-134a; Cylinder: PD; Valve: CGA 600; 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
- RL MDGPD12C996 FDA UDI
- Primary DI / UDI-DI
- 00819601021853 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
- Pressure — 81.9 Pound per Square Inch FDA UDIWeight — 1000 Gram FDA UDI
Applied Medical Laser by Airgas Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Airgas Usa Llc
Sources (1)
- FDA UDI 940e9d40-0bb8-461b-ac5c-7e1576b799a1 38 fields · synced Jun 8, 2026