HME HumidStar Trach Plus
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- HME HumidStar Trach Plus EUDAMEDFDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Model / Reference
- MP05750 EUDAMEDFDA UDI2080436K19T020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675547310 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867512080436K19T020SF EUDAMED
- FDA Product Code
- BYD FDA UDI
- EMDN Code
- R040201 TRACHEOSTOMY HUMIDIFIERS 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Heat/moisture exchanger, single-use
HME HumidStar Trach Plus by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI c3c2e436-3b42-4a9c-b447-a19a69784078 32 fields · synced Jul 17, 2026
- EUDAMED f45292f9-a0c5-41a8-a727-ed363b560713 61 fields · synced Jul 17, 2026