FDA UDI
In Commercial Distribution
🇺🇸 United States
AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V
DI: 05060485030713
·
Model: AN4000.61
·
ANDERSEN STERILIZERS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V
- Primary DI
- 05060485030713
- Version / Model
- AN4000.61
- Catalog Number
- AN4000.61
- Company Name
- ANDERSEN STERILIZERS INC.
- Labeler DUNS
- 931853006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-31
- Public Version
- 1
- Public Version Date
- 2023-09-08
- Public Version Status
- New
- Public Device Record Key
- b6d1fcd6-fb99-4739-9e84-d9cb308ac24b
Device Description
EOGas 4 Sterilizer 3 & 6 Hour Cycle, 230V
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
- No
- 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 |
|---|---|---|---|---|
| FLF | Sterilizer, Ethylene-Oxide Gas | General Hospital | 880.6860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13740 | Ethylene oxide sterilizer | A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using ethylene oxide (ETO) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and packed in gas permeable wraps; a means to introduce the gas into the chamber; and controls to chose one of the sterilization cycles. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060485030713 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192978 | 000 |