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Passy-Muir™ Valve Oxygen Adapter (PMA™ 2000)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PMA 2000
Identity
- Trade Name
- Passy-Muir™ Valve Oxygen Adapter (PMA™ 2000) EUDAMEDPassy-Muir FDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- Passy-Muir™ Valve Oxygen Adapter (PMA™ 2000) EUDAMEDPassy-Muir® Valve Oxygen Adapter PMA® 2000 FDA UDI
- Model / Reference
- PMA 2000 EUDAMEDFDA UDI
- Description
- Passy-Muir® Valve Oxygen Adapter PMA® 2000 FDA UDI
Identifiers
- Catalog Number
- PMA 2000 FDA UDI
- Primary DI / UDI-DI
- 20859760005084 EUDAMED10859760005087 FDA UDI
- Basic UDI-DI
- 0859760005PMA2000AV EUDAMEDB-20859760005084 EUDAMED
- 510(k) Number
- K970365 FDA UDI
- FDA Product Code
- JOH FDA UDI
- EMDN Code
- R900680 PHONATION VALVES - ACCESSORIES 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™ Valve Oxygen Adapter (PMA™ 2000) by Passy-Muir, Inc. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0859760005PMA2000AV | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0859760005PMA2000AV | 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 071ae6a9-923d-4b5e-b746-3f9cb5555e1d 61 fields · synced Jul 11, 2026
- EUDAMED c457abf3-bd2d-4ae1-a552-d6e73190d196 61 fields · synced May 19, 2026
- FDA UDI 48676dac-7313-401f-a0f3-4fb358701e30 36 fields · synced May 30, 2026