Identity
- Trade Name
- Bact-HME Midi Port FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Device Name
- HME Filter FDA UDI
- Model / Reference
- 6310 FDA UDI
- Description
- HME Filter FDA UDI
Identifiers
- Catalog Number
- 6310 FDA UDI
- Primary DI / UDI-DI
- 30734000671946 FDA UDI
- 510(k) Number
- K202459 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Heat/moisture exchanger/microbial medical gas filter 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
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 — 8.5 Centimeter FDA UDI
Category: Heat/moisture exchanger/microbial medical gas filter
Bact-HME Midi Port by Pharma Systems Ps AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Heat/moisture exchanger/microbial medical gas filter.
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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 Basic — Pharma Systems Ps AB
- Bact-HME Midi 1/2 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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pharma Systems Ps AB
Sources (1)
- FDA UDI 20b1a25f-89f1-4f2f-bd4e-69e328396c40 37 fields · synced Jun 8, 2026