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PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE…
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref PMV 2001
Identity
- Trade Name
- PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2001 (Purple Color™) 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™ 2001 (Purple Color™) EUDAMEDPassy-Muir® Low Profile Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 2001 (Purple Color™) FDA UDI
- Model / Reference
- PMV 2001 EUDAMEDFDA UDI
- Description
- Passy-Muir® Low Profile Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 2001 (Purple Color™) FDA UDI
Identifiers
- Catalog Number
- PMV 2001 FDA UDI
- Primary DI / UDI-DI
- 20859760005145 EUDAMED10859760005148 FDA UDI
- Basic UDI-DI
- B-20859760005145 EUDAMED0859760005PMV2001J6 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 — FDA_510K, MDR, MDD — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962714 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-20859760005145 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-20859760005145 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Passy-Muir, Inc.
- EUDAMED SRN
- US-MF-000002288
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED c54234b1-4143-4ac0-aa4a-ffb9932bd3ec 61 fields · synced Jun 19, 2026
- EUDAMED ac09a330-4dcc-4643-ab61-02460eafedb3 61 fields · synced May 17, 2026
- FDA UDI 6adcfe08-c940-4950-a906-76d6a8e9c3a7 36 fields · synced May 29, 2026
- FDA 510(k) K962714 1 fields · synced May 18, 2026