FDA UDI
In Commercial Distribution
🇺🇸 United States
OriginAL Pure Cryogen
DI: 00819601020016
·
Model: RLMDGPD12C840
·
AIRGAS USA LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OriginAL Pure Cryogen
- Primary DI
- 00819601020016
- Version / Model
- RLMDGPD12C840
- Catalog Number
- RLMDGPD12C840
- Company Name
- AIRGAS USA LLC
- Labeler DUNS
- 831996595
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-13
- Public Version
- 3
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- a8d024f6-4d1f-442e-85c0-f59dfc9bfb8a
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16635 | Freon gas cartridge | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819601020016 | GS1 | ||||
| Package | 10819601020013 | GS1 | Case | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-233-4334
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1000 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius