Montgomery® Initial Cannula Set

FDA UDI

Class II (US FDA UDI)

by Boston Medical Products, Inc.

Identity

Trade Name: Montgomery® Initial Cannula Set FDA UDI
Generic Name: Tracheotome FDA UDI
Device Name: Size: 8. Contains one each of 330801 & 341008. FDA UDI
Model / Reference: 330800 FDA UDI
Description: Size: 8. Contains one each of 330801 & 341008. FDA UDI

Identifiers

Catalog Number: 330800 FDA UDI
Primary DI / UDI-DI: EBES3308001 FDA UDI
FDA Product Code: BTO FDA UDI
FZT FDA UDI
GMDN Term: Tracheotome FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5800 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Category: Tracheostoma button Tracheotome

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

Similar devices

Also classified as Tracheotome.

Montgomery® Tracheal Fenestrator — Boston Medical Products, Inc. · Class I
Montgomery® Initial Cannula Set — Boston Medical Products, Inc. · Class II
Montgomery® Initial Cannula Set — Boston Medical Products, Inc. · Class II
Montgomery® Initial Cannula Set — Boston Medical Products, Inc. · Class II
Montgomery® Tracheal Fenestrator — Boston Medical Products, Inc. · Class I
Montgomery® Initial Cannula Set — Boston Medical Products, Inc. · Class II
Montgomery® Initial Cannula Set — Boston Medical Products, Inc. · Class II
Montgomery® Initial Cannula Set — Boston Medical Products, Inc. · Class II

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 c5c5b014-4622-41de-8889-7d50266fabac 37 fields · synced Jun 9, 2026