Identity
- Trade Name
- EOGas 4 Refill Kit FDA UDI
- Generic Name
- Ethylene oxide sterilizer FDA UDI
- Device Name
- AN1004.01 EOGas 4 Refill Kit, CA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips, 17 EOGas 4 sterilization bags FDA UDI
- Model / Reference
- AN1004.01 FDA UDI
- Description
- AN1004.01 EOGas 4 Refill Kit, CA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips, 17 EOGas 4 sterilization bags FDA UDI
Identifiers
- Catalog Number
- AN1004.01 FDA UDI
- Primary DI / UDI-DI
- 05060485030454 FDA UDI
- 510(k) Number
- K150646 FDA UDI
- FDA Product Code
- FLF FDA UDI
- GMDN Term
- Ethylene oxide sterilizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ethylene oxide sterilizer
EOGas 4 Refill Kit by Andersen Sterilizers, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ethylene oxide sterilizer.
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Cleared under the same submission
K150646 also covers:
- AN1071 Humidichip — Andersen Sterilizers, Inc.
- AN1071 Humidichip — Andersen Sterilizers, Inc.
- EOGas 4 Ethylene Oxide Gas Sterilizer — Andersen Sterilizers, Inc.
- EOGas 4 Ethylene Oxide Gas Sterilizer — Andersen Sterilizers, Inc.
- EOGas 4 Refill Kit — Andersen Sterilizers, Inc.
- EOGas 4 Refill Kit — Andersen Sterilizers, Inc.
- EOGas 4 Sterilization Bag — Andersen Sterilizers, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Andersen Sterilizers, Inc.
Sources (1)
- FDA UDI ca35f328-7b3f-486f-9a59-f8d7fb71fc18 37 fields · synced Jun 1, 2026