Forsure

FDA UDI

Class II (US FDA UDI)

by Forsure Medical Products Llc

Identity

Trade Name: Forsure FDA UDI
Generic Name: Reinforced endotracheal tube, single-use FDA UDI
Device Name: An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. It is wire reinforced to prevent kinking during patient movement and may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) have a built-in pilot balloon. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device. FDA UDI
Model / Reference: 11290035 FDA UDI
Description: An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. It is wire reinforced to prevent kinking during patient movement and may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) have a built-in pilot balloon. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device. FDA UDI

Identifiers

Catalog Number: 11290035 FDA UDI
Primary DI / UDI-DI: 00815123011549 FDA UDI
510(k) Number: K073383 FDA UDI
FDA Product Code: BTR FDA UDI
GMDN Term: Reinforced endotracheal tube, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5730 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 — 3.5 Millimeter FDA UDI

Category: Reinforced endotracheal tube, single-use

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

Similar devices

Also classified as Reinforced endotracheal tube, single-use.

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Disposable Tracheal tubes — Shaoxing Carere Medical Appliance Co., Ltd. · Class IIa
Disposable Tracheal Tubes With Cuff — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
cuff — Contec Medical Systems Co., Ltd. · Class I
RUSCH — TELEFLEX INCORPORATED · Class II
Welllead Reinforced Tracheal Tube — Well Lead Medical Co., Ltd · Class IIa
Disposable Endotracheal Tubes — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
Endotracheal Tube — HANGZHOU FORMED MEDICAL DEVICES CO., LTD. · Class IIa

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

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Manufacturer

Manufacturer: Forsure Medical Products Llc

Sources (1)

FDA UDI bb9a356b-ab80-474f-ad65-f2939fc09025 37 fields · synced Jun 8, 2026