FDA UDI
In Commercial Distribution
🇺🇸 United States
EOGas 4 Ethylene Oxide Gas Sterilizer
DI: 05060485030409
·
Model: AN4000.11
·
ANDERSEN STERILIZERS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EOGas 4 Ethylene Oxide Gas Sterilizer
- Primary DI
- 05060485030409
- Version / Model
- AN4000.11
- Catalog Number
- AN4000.11
- Company Name
- ANDERSEN STERILIZERS INC.
- Labeler DUNS
- 931853006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-01
- Public Version
- 1
- Public Version Date
- 2018-10-02
- Public Version Status
- New
- Public Device Record Key
- 36e10333-10b1-45a2-b920-3836cf999059
Device Description
AN4000.11 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 05060485030409 | GS1 |
Customer Contacts
- Phone
- 800-523-1276
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150646 | 000 |