Identity
- Trade Name
- Bact-HME Basic FDA UDI
- Generic Name
- Microbial medical gas filter, single-use FDA UDI
- Device Name
- Heat and Moisture Exchangers (HMEs), Bacterial/Viral Filters (BVFs), and combined HMEF devices EUDAMEDHME Filter FDA UDI
- Model / Reference
- 6000 EUDAMEDFDA UDI
- Description
- HME Filter FDA UDI
Identifiers
- Catalog Number
- 6000 FDA UDI
- Primary DI / UDI-DI
- 30734000671007 EUDAMEDFDA UDI
- Basic UDI-DI
- 73400067600075 EUDAMED
- 510(k) Number
- K202459 FDA UDI
- FDA Product Code
- CAH FDA UDI
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
- GMDN Term
- Microbial medical gas filter, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5260 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 8.6 Centimeter FDA UDI
Category: Microbial medical gas filter, single-use
Bact-HME Basic by Pharma Systems Ps AB — 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
K202459 also covers:
- Bact-HME 1/2 Basic — Pharma Systems Ps AB
- Bact-HME 1/2 Port — Pharma Systems Ps AB
- Bact-HME Midi 1/2 Port — Pharma Systems Ps AB
- Bact-HME Midi Port — Pharma Systems Ps AB
- Bact-HME Midi Port Angle — Pharma Systems Ps AB
- Bact-HME Port — Pharma Systems Ps AB
- Bact-Trap Basic — Pharma Systems Ps AB
- Bact-Trap Midi Port — Pharma Systems Ps AB
- Bact-Trap Midi Port Angle — Pharma Systems Ps AB
- Bact-Trap Mini Basic — Pharma Systems Ps AB
- Bact-Trap Mini Port — Pharma Systems Ps AB
- Bact-Trap Mini Port 2 — Pharma Systems Ps AB
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
- Pharma Systems Ps AB
Sources (2)
- FDA UDI 1fc9ef86-e676-4a2a-aace-c5129226aed5 37 fields · synced Jun 18, 2026
- EUDAMED 03e74860-fb32-4d94-bc52-ba6543933652 61 fields · synced Jun 18, 2026