Identity
- Trade Name
- Pharma Trach Multipack EUDAMEDPharma Trach Basic Multipack FDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- Tracheal HMEs and supporting devices EUDAMEDHME FDA UDI
- Model / Reference
- 6245 EUDAMEDFDA UDI
- Description
- HME FDA UDI
Identifiers
- Catalog Number
- 6245 FDA UDI
- Primary DI / UDI-DI
- 30734000671632 EUDAMEDFDA UDI
- Basic UDI-DI
- 7340006762407T 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 — 205 Centimeter FDA UDI
Category: Heat/moisture exchanger, single-use
Pharma Trach Basic Multipack 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 78a3f0b0-e31c-4d68-9828-d6365a44dfb9 36 fields · synced Jul 8, 2026
- EUDAMED b3e892d5-9dcd-4dd6-920a-05cf13d1ef2e 61 fields · synced Jul 8, 2026