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PASSY-MUIR™ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (w…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PMV 005Model PMV 005
Identity
- Trade Name
- PASSY-MUIR™ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (white) EUDAMEDPassy-Muir FDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- PASSY-MUIR™ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (white) EUDAMEDPassy-Muir® Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 005 (white) FDA UDI
- Model / Reference
- PMV 005 EUDAMEDFDA UDI
- Description
- Passy-Muir® Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 005 (white) FDA UDI
Identifiers
- Catalog Number
- PMV 005 FDA UDI
- Primary DI / UDI-DI
- 20859760005015 EUDAMED10859760005018 FDA UDI
- Basic UDI-DI
- 0859760005PMV005AN EUDAMEDB-20859760005015 EUDAMED
- FDA Product Code
- BTO FDA UDIJOH FDA UDI
- EMDN Code
- R90060201,R90060202 EUDAMEDR900602 PHONATION VALVES FOR TRACHEOSTOMY EUDAMED
- GMDN Term
- Tracheostomy tube speech valve FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
PASSY-MUIR™ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (w… by Passy-Muir, Inc. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0859760005PMV005AN | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0859760005PMV005AN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Passy-Muir, Inc.
- EUDAMED SRN
- US-MF-000002288
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 4623edad-1106-4801-9320-05135ca21b91 61 fields · synced Jul 10, 2026
- EUDAMED 82a27198-14b6-4eed-a114-d9a0fecb93bc 61 fields · synced May 19, 2026
- FDA UDI 348ab892-fb4d-49a8-a01b-8e051772f861 36 fields · synced May 30, 2026