VentiSeal Reinforced ET Tube ID 4.0 - Sterile - USA

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name: VentiSeal Reinforced ET Tube ID 4.0 - Sterile - USA FDA UDI
Generic Name: Reinforced endotracheal tube, single-use FDA UDI
Model / Reference: 038-975-040U FDA UDI

Identifiers

Primary DI / UDI-DI: 05055788707370 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

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

FDA UDI

Category: Reinforced endotracheal tube, single-use

VentiSeal Reinforced ET Tube ID 4.0 - Sterile - USA by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Reinforced endotracheal tube, single-use.

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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: Flexicare Medical Limited

Sources (1)

FDA UDI 88988709-d352-49ee-b48a-56b269a5aa0b 32 fields · synced May 30, 2026