Identity
- Trade Name
- 3M™ Steri-Vac™ FDA UDI
- Generic Name
- Ethylene oxide sterilizer FDA UDI
- Device Name
- 3M™ Steri-Vac™ Sterilizer/Aerator GS Series, GS5-1D FDA UDI
- Model / Reference
- GS5-1D FDA UDI
- Description
- 3M™ Steri-Vac™ Sterilizer/Aerator GS Series, GS5-1D FDA UDI
Identifiers
- Catalog Number
- GS5-1D FDA UDI
- Primary DI / UDI-DI
- 00707387787561 FDA UDI
- 510(k) Number
- K142034 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ethylene oxide sterilizer
3M™ Steri-Vac™ by 3m Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ethylene oxide sterilizer.
- EOGas 4 Sterilization Bag — Andersen Sterilizers, Inc. · Class II
- EOGas 4 Ethylene Oxide Gas Sterilizer — Andersen Sterilizers, Inc. · Class II
- AN1071 Humidichip — Andersen Sterilizers, Inc. · Class II
- AN1071 Humidichip — Andersen Sterilizers, Inc. · Class II
- Anprolene AN75 Ethylene Oxide Sterilizer, 115V — Andersen Sterilizers, Inc. · Class II
- Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V — Andersen Sterilizers, Inc. · Class II
- Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V — Andersen Sterilizers, Inc. · Class II
- Anprolene AN75 Ethylene Oxide Sterilizer — Andersen Sterilizers, Inc. · Class II
Cleared under the same submission
K142034 also covers:
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
- 3m Company
Sources (1)
- FDA UDI 70b377a9-73da-4936-8db7-bbb62306668f 36 fields · synced May 30, 2026