Vortran Manometer

FDA UDI

Class II (US FDA UDI)

by Vortran Medical Technology 1, Inc.

Identity

Trade Name: VORTRAN MANOMETER FDA UDI
Generic Name: Airway pressure monitor, non-powered FDA UDI
Device Name: The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the range of 0 to 60 cm-H2O. The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O; ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O. The manometer design requirements include: the pressure range of 0 to 60 cm-H2O, connection to a breathing circuit via a 22 mm male-female adaptor, and having a life expectancy as a single patient multiple use device. It accommodates connections through the option of a 22 mm tee or 15 mm port. The manometer includes a translucent enclosure that allows the pressure indicator needle to be seen from all sides. FDA UDI
Model / Reference: 6031 FDA UDI
Description: The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the range of 0 to 60 cm-H2O. The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O; ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O. The manometer design requirements include: the pressure range of 0 to 60 cm-H2O, connection to a breathing circuit via a 22 mm male-female adaptor, and having a life expectancy as a single patient multiple use device. It accommodates connections through the option of a 22 mm tee or 15 mm port. The manometer includes a translucent enclosure that allows the pressure indicator needle to be seen from all sides. FDA UDI

Identifiers

Catalog Number: 6031 FDA UDI
Primary DI / UDI-DI: 10637320060314 FDA UDI
510(k) Number: K153733 FDA UDI
FDA Product Code: CAP FDA UDI
GMDN Term: Airway pressure monitor, non-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2600 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Airway pressure monitor, non-powered

Vortran Manometer by Vortran Medical Technology 1, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K153733 also covers:

VORTRAN MANOMETER — VORTRAN MEDICAL TECHNOLOGY 1, INC.

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: Vortran Medical Technology 1, Inc.

Sources (1)

FDA UDI 85284295-7db6-4bda-93fa-b3fbd172a5c0 35 fields · synced May 30, 2026