← Back to catalogue
Maxi-Pleat
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 4020/10BAUA001/0001Ref 4244/702BASA001/0001Ref 4244/702BSSA001/0001Ref 4244/702BSSA100/0001
Identity
- Trade Name
- Maxi pleat EUDAMEDMAXI Maxi Pleat EUDAMEDMaxi-Pleat FDA UDI
- Generic Name
- Microbial medical gas filter, single-use FDA UDI
- Device Name
- Gas and Suction Filters EUDAMEDRespiratory Filters - Various EUDAMED
- Model / Reference
- 4020/10BAUA001/0001 EUDAMED4244/702BASA001/0001 EUDAMED4244/702BSSA001/0001 EUDAMED4244/702BSSA100/0001 EUDAMED6888/20BAUA001/0001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060120952165 EUDAMED05060511620895 EUDAMED05060511622714 EUDAMED05060511620246 EUDAMED15060120952568 FDA UDI
- Basic UDI-DI
- 506012095Class1L9 EUDAMED506012095Cat277 EUDAMED
- 510(k) Number
- K033008 FDA UDI
- FDA Product Code
- CAH FDA UDI
- EMDN Code
- R040199 VENTILATION FILTERS - OTHER EUDAMED
- GMDN Term
- Microbial medical gas filter, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5260 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMED
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Maxi-Pleat by Gvs Filter Technology Uk Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- Multi-Vent — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gvs Filter Technology Uk Ltd
Sources (5)
- FDA UDI d137a2d8-47e8-4a9d-aca8-932a852999f7 34 fields · synced Jul 31, 2026
- EUDAMED 0b2f550e-007f-4aee-8462-9026e6d901ad 61 fields · synced Jul 10, 2026
- EUDAMED fd9a137a-bbb4-42bc-b1df-81ec56568703 61 fields · synced Jul 15, 2026
- EUDAMED b54b7c89-9e62-4204-8844-a752f5e93b74 61 fields · synced Jul 27, 2026
- EUDAMED 7d657a1c-a2e7-48e4-8ba4-ed70cafb2b0d 61 fields · synced Jul 31, 2026