FDA UDI
In Commercial Distribution
🇺🇸 United States
Alcon Laboratories Inc.
DI: 00819601025790
·
Model: ISPAN
·
Airgas Therapeutics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alcon Laboratories Inc.
- Primary DI
- 00819601025790
- Version / Model
- ISPAN
- Catalog Number
- 8065000326
- Company Name
- Airgas Therapeutics, LLC
- Labeler DUNS
- 118537769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-19
- Public Version
- 2
- Public Version Date
- 2026-04-01
- Public Version Status
- Update
- Public Device Record Key
- 0a14ea7a-cd93-4239-86e7-60dad9dfc7b7
Device Description
ISPAN Dual Stage Regulator; CGA 180; For Alcon Laboratories Inc.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | Anesthesiology | 868.2700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48035 | Intraocular gas cylinder regulator | A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a gas cylinder used to deliver intraocular gas [i.e., sulfur hexafluoride (SF6) or perfluoropropane (C3F8) used as a tamponade for retinal surgery] to lower high, variable gas pressure to a lower, constant working pressure. It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures and usually a manometer or manometers to display the available gas reserve of a gas cylinder and the working pressure. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819601025790 | GS1 |