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PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PMV 2000
Identity
- Trade Name
- PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2000 (clear) EUDAMEDPassy-Muir FDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2000 (clear) EUDAMEDPassy-Muir® Low Profile Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 2000 (clear) FDA UDI
- Model / Reference
- PMV 2000 EUDAMEDFDA UDI
- Description
- Passy-Muir® Low Profile Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 2000 (clear) FDA UDI
Identifiers
- Catalog Number
- PMV 2000 FDA UDI
- Primary DI / UDI-DI
- 20859760005060 EUDAMED10859760005063 FDA UDI
- Basic UDI-DI
- B-20859760005060 EUDAMED0859760005PMV2000J4 EUDAMED
- 510(k) Number
- K962714 FDA UDI
- 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™ LOW PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE… by Passy-Muir, Inc. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-20859760005060 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-20859760005060 | 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 b3c18ac8-023d-4439-b004-174d8147a712 61 fields · synced Jul 30, 2026
- EUDAMED 1d979520-37da-4c53-922a-65d26a61e29c 61 fields · synced May 19, 2026
- FDA UDI d248d5d2-0a10-4e50-839f-688dd5be0474 36 fields · synced May 29, 2026