Identity
- Trade Name
- 4244/M/711BRSA059/0001 FDA UDI
- Generic Name
- Microbial medical gas filter, single-use FDA UDI
- Device Name
- 62.002.0099.4244/M/711BRSA FDA UDI
- Model / Reference
- DYNJAAHMEHEPA FDA UDI
- Description
- 62.002.0099.4244/M/711BRSA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10080196149780 FDA UDI
- 510(k) Number
- K033008 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Microbial medical gas filter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 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
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
4244/M/711brsa059/0001 by GVS Technology (Suzhou) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microbial medical gas filter, single-use.
- ECO slimline — GVS Filter Technology UK Ltd · Class IIa
- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Ventlab — Ventlab Corp. · Class II
- 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
Cleared under the same submission
K033008 also covers:
- AirLife™ — Airlife, Inc.
- AQUESURE FILTER HUMIDIFIER — BOMImed Inc
- ECO HMEF — GVS FILTER TECHNOLOGY UK LTD
- ECO Maxi Filter — GVS FILTER TECHNOLOGY UK LTD
- ECO Range — GVS FILTER TECHNOLOGY UK LTD
- HEPA Ventilation Filter — GVS FILTER TECHNOLOGY UK LTD
- High Deadspace Body — GVS FILTER TECHNOLOGY UK LTD
- L4 New Intake Filter — GVS FILTER TECHNOLOGY UK LTD
- Maxi-Pleat — GVS FILTER TECHNOLOGY UK LTD
- Multi-Vent — GVS FILTER TECHNOLOGY UK LTD
- Multi-Vent — GVS FILTER TECHNOLOGY UK LTD
- Multi-Vent — GVS FILTER TECHNOLOGY UK LTD
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
- GVS Technology (Suzhou) Co., Ltd.
Sources (1)
- FDA UDI 5a797f0e-8f9a-4c74-b65f-125fa2d43f1a 35 fields · synced May 30, 2026