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Montgomery Long-Term Cannula

by Boston Medical Products, Inc. 24 variants

Ref 330865

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4063107TCSAM Basic UDI-DI 14063107100793UDI-DIDate5 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number14063107100793 UDI-DI Date30 Sep 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Tracheostoma button
Device Name
Montgomery Cannula System
Model / Ref / Catalog
330865
Primary DI / UDI-DI
14063107100793
Basic UDI-DI
4063107TCSAM
510(k) Number
FDA Product Code
BTO
EMDN Code
R010503 Tracheostomy inner cannulas
GMDN Term
Tracheostoma button
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Outer Diameter — 12 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017994
Authorised representative
bess medizintechnik gmbh DE-AR-000006514

Other devices from Boston Medical Products, Inc.

See all devices from Boston Medical Products, Inc. →

Properties

  • Sterile
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No