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PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY SWALLOWING AND SPEAKING VALVE PMV™ 2020 (c…

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref PMV 2020Ref PMV™ 2020 (clear)

by Passy-Muir, Inc.

Identity

Trade Name
PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY SWALLOWING AND SPEAKING VALVE PMV™ 2020 (clear) EUDAMED
Passy-Muir FDA UDI
Generic Name
Tracheostomy tube speech valve FDA UDI
Device Name
PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY SWALLOWING AND SPEAKING VALVE PMV™ 2020 (clear) EUDAMED
Passy-Muir® Low Profile Tracheostomy Swallowing and Speaking Valve PMV® 2020 (clear) FDA UDI
Model / Reference
PMV 2020 EUDAMEDFDA UDI
PMV™ 2020 (clear) EUDAMED
Description
Passy-Muir® Low Profile Tracheostomy Swallowing and Speaking Valve PMV® 2020 (clear) FDA UDI

Identifiers

Catalog Number
PMV 2020 FDA UDI
Primary DI / UDI-DI
20859760005039 EUDAMED
10859760005032 FDA UDI
Basic UDI-DI
0859760005PMV2020JA EUDAMED
B-20859760005039 EUDAMED
510(k) Number
K990905 FDA UDI
FDA Product Code
JOH FDA UDI
EMDN Code
R90060202 PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE EUDAMED
GMDN Term
Tracheostomy tube speech valve FDA UDI

Classification

Device Class
Class I EUDAMED
Class IIa EUDAMED
Class 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 SWALLOWING AND SPEAKING VALVE PMV™ 2020 (c… by Passy-Muir, Inc. — Class I — MDD, FDA_510K, MDR — listed in EUDAMED, FDA…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Active

FDA_510K

European Union Active

CE/MDR

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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 47739e99-7f93-4997-a3f4-96979903477e 61 fields · synced Jul 20, 2026
  • EUDAMED 45578cea-4525-40a7-b076-379131e1a657 61 fields · synced May 19, 2026
  • FDA UDI 1a21d4e9-824b-41f7-9967-eccf50b2e486 36 fields · synced May 30, 2026
  • FDA 510(k) K990905 1 fields · synced May 18, 2026