Identity
- Trade Name
- Gas Filter Unit FDA UDI
- Generic Name
- Microbial medical gas filter, single-use FDA UDI
- Device Name
- Gas Filter Unit, Box of 10 FDA UDI
- Model / Reference
- ACC-GFU-100 FDA UDI
- Description
- Gas Filter Unit, Box of 10 FDA UDI
Identifiers
- Catalog Number
- ACC-GFU-100 FDA UDI
- Primary DI / UDI-DI
- 10894338002693 FDA UDI
- 510(k) Number
- K073409 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Microbial medical gas filter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microbial medical gas filter, single-use
Gas Filter Unit by Omniguide, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Microbial medical gas filter, single-use.
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- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- Ventlab — Ventlab Corp. · Class II
- Pentair — Pentair Filtration Solutions · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
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
- Omniguide, Inc.
Sources (1)
- FDA UDI 678ad991-8ed6-406b-b5a6-ac9bbb631c26 35 fields · synced Jun 8, 2026