Forsure

FDA UDI

Class II (US FDA UDI)

by Forsure Medical Products Llc

Identity

Trade Name: Forsure FDA UDI
Generic Name: Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI
Device Name: A sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device. FDA UDI
Model / Reference: 11110040 FDA UDI
Description: A sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device. FDA UDI

Identifiers

Catalog Number: 11110040 FDA UDI
Primary DI / UDI-DI: 00815123011396 FDA UDI
510(k) Number: K042684 FDA UDI
FDA Product Code: BTO FDA UDI
GMDN Term: Tracheostomy tube, non-reinforced, non-customized, single-use 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

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

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

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 4.0 Millimeter FDA UDI

Category: Tracheostomy tube, non-reinforced, non-customized, single-use

Forsure by Forsure Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Shiley — Covidien LP · Class II
TRACOE mini — Tracoe medical GmbH · Class II
PRIMEDISILK® Silikonkanüle, Gr.10 Länge 62 mm ohne Konnektor — Primed Halberstadt Medizintechnik GmbH · Class IIb
Tracheal Stent with Mesh and Posts — HOOD, E BENSON LABORATORIES INC · Class II
Trachealkanüle PRIMEDISTOM®, Gr.10, L = 85 mm — Primed Halberstadt Medizintechnik GmbH · Class IIb
Shiley — Covidien LP · Class II
Trachealkanüle Ultrasoft Suction Gr.8 — Primed Halberstadt Medizintechnik GmbH · Class IIb
Silber Innenkanüle mit Adaptionsring für rundes Kastenventil gesiebt — Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH · Class IIb

Cleared under the same submission

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Forsure Medical Products Llc

Sources (1)

FDA UDI f1ae1271-53e1-497a-8643-34171fb4ca82 37 fields · synced Jun 8, 2026

Forsure

Identity

Identifiers

Classification

Clinical & Handling

Dimensions & Sizes

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)