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PASSY-MUIR™ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 007 (A…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PMV 007Ref PMV 007
Identity
- Trade Name
- PASSY-MUIR™ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 007 (Aqua Color™) EUDAMEDPassy-Muir FDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- PASSY-MUIR™ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 007 (Aqua Color™) EUDAMEDPASSY-MUIR™ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE VALVE PMV™ 007 (Aqua Color™) EUDAMEDPassy-Muir® Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 007 (Aqua Color™) FDA UDI
- Model / Reference
- PMV 007 EUDAMEDFDA UDI
- Description
- Passy-Muir® Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 007 (Aqua Color™) FDA UDI
Identifiers
- Catalog Number
- PMV 007 FDA UDI
- Primary DI / UDI-DI
- 20859760005022 EUDAMED10859760005025 FDA UDI
- Basic UDI-DI
- 0859760005PMV007AS EUDAMEDB-20859760005022 EUDAMED
- FDA Product Code
- JOH FDA UDI
- EMDN Code
- R90060201,R90060202 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™ 007 (A… 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 | 0859760005PMV007AS | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0859760005PMV007AS | 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 f9f6bc86-29f5-4e93-8712-8ceff9f70eed 61 fields · synced Oct 6, 2026
- EUDAMED bee0c3b6-a44b-46c8-83bc-43efebba62a8 61 fields · synced May 18, 2026
- FDA UDI 9fe12a39-d33a-4658-b88a-4915743ac95e 36 fields · synced May 30, 2026