Identity
- Trade Name
- Pharma Neo Port EUDAMEDFDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- Heat and Moisture Exchangers (HMEs), Bacterial/Viral Filters (BVFs), and combined HMEF devices EUDAMEDHME FDA UDI
- Model / Reference
- 6220 EUDAMEDFDA UDI
- Description
- HME FDA UDI
Identifiers
- Catalog Number
- 6220 FDA UDI
- Primary DI / UDI-DI
- 30734000671601 EUDAMEDFDA UDI
- Basic UDI-DI
- 73400067600075 EUDAMED
- FDA Product Code
- BYD FDA UDI
- EMDN Code
- R060299 HUMIDIFICATION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Heat/moisture exchanger, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5375 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
Yes
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 — 3.6 Centimeter FDA UDI
Category: Heat/moisture exchanger, single-use
Pharma Neo Port by Pharma Systems Ps AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pharma Systems Ps AB
Sources (2)
- FDA UDI 2bb41402-0fcf-4899-bd50-f94b5929eb72 36 fields · synced Jul 8, 2026
- EUDAMED 992edc7d-8a1e-49ce-920e-374c13c46783 61 fields · synced Jul 8, 2026