Venner™ PneuX P.Y.™ ETT MRI

FDA UDI

Class II (US FDA UDI)

by Venner Medical (singapore) Pte. Ltd.

Identity

Trade Name: Venner™ PneuX P.Y.™ ETT MRI FDA UDI
Generic Name: Reinforced endotracheal tube, single-use FDA UDI
Device Name: The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended periods (not more than 30 days) of intensive or critical care, and for evacuation or drainage of secretion from the subglottic space. It is also safety in an MRI environment (indicated MRI) and compatible with Tracheal intubation during routine anaesthesia. FDA UDI
Model / Reference: 901160 FDA UDI
Description: The Venner™ PneuX P.Y.™ Endotracheal tube is designed to be used for patients undergoing Tracheal intubation during extended periods (not more than 30 days) of intensive or critical care, and for evacuation or drainage of secretion from the subglottic space. It is also safety in an MRI environment (indicated MRI) and compatible with Tracheal intubation during routine anaesthesia. FDA UDI

Identifiers

Catalog Number: 901160 FDA UDI
Primary DI / UDI-DI: 08885009190752 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

Yes

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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 6 Millimeter FDA UDI

Category: Reinforced endotracheal tube, single-use

Venner™ PneuX P.Y.™ ETT MRI by Venner Medical (singapore) Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reinforced endotracheal tube, single-use.

Rurka intubacyjna bez mankietu — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
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
Disposable Endotracheal Tube — Tianjin Plastics Research Institute Co., Ltd. · Class IIa
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

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: Venner Medical (singapore) Pte. Ltd.

Sources (1)

FDA UDI 4c15fc49-e8c4-4792-aa92-8c5bcfbc98d1 35 fields · synced May 30, 2026