DEVICE: EOGas 4 Refill Kit (05060485030164)
Device Identifier (DI) Information
EOGas 4 Refill Kit
AN1004.00
In Commercial Distribution
AN1004.00
ANDERSEN STERILIZERS INC.
AN1004.00
In Commercial Distribution
AN1004.00
ANDERSEN STERILIZERS INC.
AN1004.00 EOGas 4 Refill Kit, 25 EO 17.6g cartridges, 25 AN1087 Dosimeters, 25 Humidichips, 26 EOGas 4 sterilization bags
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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FLF | Sterilizer, Ethylene-Oxide Gas |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K150646 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b0811fb5-9ea5-4a39-8e6c-3b99be5ccbba
October 02, 2018
1
September 01, 2018
October 02, 2018
1
September 01, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-523-1276
customerservice@anpro.com
customerservice@anpro.com