Montgomery® Cannula Speaking Valve

FDA UDI

Class II (US FDA UDI)

by Boston Medical Products, Inc.

Identity

Trade Name: Montgomery® Cannula Speaking Valve FDA UDI
Generic Name: Tracheostomy tube speech valve FDA UDI
Device Name: Size: 4; Type: MGP FDA UDI
Model / Reference: 350402 FDA UDI
Description: Size: 4; Type: MGP FDA UDI

Identifiers

Catalog Number: 350402 FDA UDI
Primary DI / UDI-DI: EBES3504021 FDA UDI
510(k) Number: K955516 FDA UDI
FDA Product Code: JOH FDA UDI
GMDN Term: Tracheostomy tube speech valve FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Tracheostomy tube speech valve

Montgomery® Cannula Speaking Valve by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K955516 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Boston Medical Products, Inc.

Sources (1)

FDA UDI 3fb270b8-0417-4fe4-945f-f7a1faa853b0 38 fields · synced Jun 9, 2026