Question 1

What types of devices does Boston Medical Products, Inc. manufacture?

Accepted Answer

Boston Medical Products, Inc. manufactures trachea prostheses, laryngectomy tubes, polymeric laryngeal stents, intranasal splints (non-biodegradable), tracheostoma buttons, polymeric oesophageal stents (non-bioabsorbable), tracheostomy tube decannulation caps, and preformed vocal cord medialization implants. Example devices include the Montgomery® Salivary Bypass Tube, Montgomery® Initial Cannula Set, Montgomery® Laryngeal Keel, Montgomery® Safe-T-Tube™, Singer Laryngectomy Tube, and OTOCELL® Ear Wick.

The company's devices are classified as Class I, Class II, and unclassified (U) and are listed in the FDA UDI registry. Boston Medical Products, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Boston Medical Products, Inc. based?

Accepted Answer

Boston Medical Products, Inc. is based in the United States, as explicitly stated in the SUMMARY section of the device data. The COUNTRY field confirms this as US, indicating the company’s location without referencing any specific city, state, or facility details beyond the national level.

Question 3

In which regulatory registry are Boston Medical Products, Inc.'s devices listed?

Accepted Answer

Boston Medical Products, Inc.'s devices are listed in the FDA UDI registry, as indicated by the LISTED IN field in the device data. This refers to the U.S. Food and Drug Administration’s Unique Device Identification system, which tracks medical devices for regulatory purposes; the company itself is not approved or cleared—only individual devices may be authorised through this system.

Question 4

How are Boston Medical Products, Inc.'s devices classified?

Accepted Answer

Boston Medical Products, Inc.'s devices are classified as Class I, Class II, and unclassified (U), according to the DEVICE CLASSES field in the provided data. This classification reflects the risk-based regulatory framework used by the FDA, where Class I devices are low risk, Class II are moderate risk, and unclassified (U) devices have not been assigned a specific class; the company does not claim approval or clearance for any device, only that its products fall into these regulatory categories.

Device	Model / Reference	Registries	Class	Status
Har-El Pharyngeal Tube	355120R	FDA UDI	Class I	Active
Montgomery® Salivary Bypass Tube	322080R	FDA UDI	Class I	Active
Rutter Stent	840014	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	460012R	FDA UDI	Class II	Active
Custom Nasal Splint	60-315	FDA UDI	Class I	Active
Montgomery® Long-Term Cannula	331033	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	320009	FDA UDI	Class II	Active
Singer Laryngectomy Tube	SLT-0927	FDA UDI	Class I	Active
Trach Tube Cleaning Brushes	3304	FDA UDI	Class I	Active
Montgomery® Long-Term Cannula	330441	FDA UDI	Class II	Active
Doyle Ear Dressing	50-402B	FDA UDI	Class I	Active
Doyle Ear Dressing	50-402A	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	560011	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	520014	FDA UDI	Class II	Active
Doyle Open-Lumen Splint	60-203	FDA UDI	Class I	Active
Rutter Stent	840011	FDA UDI	Class II	Active
Montgomery® Thyroplasty Implant	MTF-08	FDA UDI	Class II	Active
Singer Laryngectomy Tube	SLT-1027	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	420015	FDA UDI	Class II	Active
Rutter Stent	840009	FDA UDI	Class II	Active
Singer Laryngectomy Tube	SLT-0855	FDA UDI	Class I	Active
Moore Tube 15 mm Inner Cannula	MTT-008-CN	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	62016R	FDA UDI	Class II	Active
15 mm Adaptor	310804	FDA UDI	Class II	Active
Montgomery® Long-Term Cannula	331041	FDA UDI	Class II	Active
Montgomery® Laryngeal Stent	323010	FDA UDI	Class II	Active
Singer Laryngectomy Tube	SLT-1218	FDA UDI	Class I	Active
Plug/Ring Set	321086	FDA UDI	Class II	Active
Montgomery® Thyroplasty Instrument	MT-204	FDA UDI	Class II	Active
Singer Laryngectomy Tube	SLT-0818	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™ 15 mm Adaptor	361127	FDA UDI	Class II	Active
Montgomery® Thyroplasty Implant	MTM-09	FDA UDI	Class II	Active
Post-Stop™ Epistaxis Catheter	60-403P	FDA UDI	Class I	Active
Montgomery® Cannula Speaking Valve	350602	FDA UDI	Class II	Active
RHINOCELL® Epistaxis Packing	EP-1001525	FDA UDI	Class I	Active
Montgomery® Thyroplasty Instrument	MT-208	FDA UDI	Class II	Active
Montgomery® Initial Cannula Set	330400	FDA UDI	Class II	Active
Montgomery® Long-Term Cannula	331049	FDA UDI	Class II	Active
Montgomery® Short-Term Cannula	330401	FDA UDI	Class II	Active
Rutter Stent	840015	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	42012R	FDA UDI	Class II	Active
Doyle Ear Dressing	50-402P	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™	320006	FDA UDI	Class II	Active
Montgomery® Long-Term Cannula	330433	FDA UDI	Class II	Active
Montgomery® Safe-T-Tube™	42015R	FDA UDI	Class II	Active
Rutter Stent	840010	FDA UDI	Class II	Active
Doyle Open-Lumen Splint	60-203	FDA UDI	Class I	Active
Bivalve Nasal Splint, Standard	60-302	FDA UDI	Class I	Active
Singer Laryngectomy Tube	SLT-1127	FDA UDI	Class I	Active
Montgomery® Safe-T-Tube™ Plug/Ring Set	361086	FDA UDI	Class II	Active

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