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Newport Medical Instruments

Last updated May 23, 2026

What Newport Medical Instruments makes

Newport Medical Instruments manufactures neonatal and adult intensive-care ventilators, ventilator breathing circuits (reusable), heat/moisture exchangers with microbial medical gas filters, respiratory oxygen sensors, single-use microbial medical gas filters, medical device air compressors, and single-use carbon dioxide cuvettes.

The company's portfolio includes Class I and Class II medical devices, listed in the FDA 510(k) and FDA UDI registries. Newport Medical Instruments is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does Newport Medical Instruments manufacture?

Where is Newport Medical Instruments based?

Newport Medical Instruments is based in the United States, as indicated by the country information provided in the device data.

Which regulatory registries list Newport Medical Instruments' devices?

Newport Medical Instruments' devices are listed in the FDA 510(k) and FDA UDI registries, as specified in the device data information.

How are Newport Medical Instruments' devices classified?

Newport Medical Instruments manufactures both Class I and Class II medical devices, as indicated in the device data classification information.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (163)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Newport	E360E-BR-BR	FDA UDI	Class II	Active
Newport	HT6004701	FDA UDI	Class II	Active
Newport	HT70PM-SY-EU	FDA UDI	Class II	Active
Newport	E360E-WW-UK	FDA UDI	Class II	Unknown
Newport	HT70PM-SY-UK	FDA UDI	Class II	Unknown
Newport	E360P-SY-IN	FDA UDI	Class II	Unknown
Newport	E360TH-SY-IN	FDA UDI	Class II	Unknown
Newport	E360T-US-NA	FDA UDI	Class II	Unknown
Newport	E360T-RU-IN	FDA UDI	Class II	Unknown
Newport Medical	HT600045	FDA UDI	Class I	Active
Newport	HT70PM-SY-UK	FDA UDI	Class II	Unknown
Newport	E360TH-US-NA	FDA UDI	Class II	Unknown
Newport	E360E-ES-NA	FDA UDI	Class II	Unknown
Newport	E360T1-SY-IN	FDA UDI	Class II	Unknown
Newport	HT70M-ES-EU	FDA UDI	Class II	Unknown
Newport	E360T1-WW-IN	FDA UDI	Class II	Unknown
Newport	HT70PM-ES-NA	FDA UDI	Class II	Unknown
Newport Medical	HT600049	FDA UDI	Class I	Active
Newport	E360E-WW-IN	FDA UDI	Class II	Unknown
Newport	HT70PM-SY-NA	FDA UDI	Class II	Unknown
Newport	E360T-BR-BR	FDA UDI	Class II	Unknown
Newport Medical	BCD43801P	FDA UDI	Class I	Active
Newport	HT70M-SY-EU	FDA UDI	Class II	Active
Newport	E360T-SY-IN	FDA UDI	Class II	Unknown
Newport	E360T-ES-IN	FDA UDI	Class II	Unknown
Newport	HT70PM-CN-NA	FDA UDI	Class II	Unknown
Newport	E360T-CN-NA	FDA UDI	Class II	Unknown
Newport	E360T-SY-NA	FDA UDI	Class II	Active
Newport Medical	C235-120V-60-1	FDA UDI	Class II	Active
Newport	E360E-BR-BR	FDA UDI	Class II	Active
Newport	HT70PM-CN-NA	FDA UDI	Class II	Unknown
Newport Medical	BCD43801P-EL	FDA UDI	Class I	Active
Newport Medical	BCD32820P	FDA UDI	Class I	Unknown
Newport	HT70PM-PT-BR	FDA UDI	Class II	Unknown
Newport	HT70PM-JP-NA	FDA UDI	Class II	Active
Newport	HT70M-JP-NA	FDA UDI	Class II	Unknown
Newport	E360T-WW-NA	FDA UDI	Class II	Unknown
Newport	HT70M-PT-BR	FDA UDI	Class II	Active
Newport	E360E-SY-IN	FDA UDI	Class II	Unknown
Newport	E360S-ES-NA	FDA UDI	Class II	Unknown
Newport	E360T-ES-NA	FDA UDI	Class II	Unknown
Newport	HT70PM-ES-NA	FDA UDI	Class II	Unknown
Newport	E360TH-ES-NA	FDA UDI	Class II	Unknown
Newport	E360E-SY-IN	FDA UDI	Class II	Unknown
Newport	E360S-SY-IN	FDA UDI	Class II	Unknown
Newport Medical	BCD40801P	FDA UDI	Class I	Active
Newport	HT70PM-RU-EU	FDA UDI	Class II	Unknown
Newport	HT70M-PT-BR	FDA UDI	Class II	Active
Newport Medical	PBC460A	FDA UDI	Class II	Unknown
Newport Medical	BCD22820P	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Newport Medical Instruments has 12 recall records initiated between 2005-10-29 and 2017-03-30, all with a status of terminated. The reasons for recall include issues such as component failures causing alarms or ventilator shutdowns, compatibility problems with battery packs, incorrect software versions, labeling issues, oversized power cord connectors, battery performance concerns, and low pressure transducer failures.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 30, 2017	Z-1874-2017	—	terminated	Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm.
Apr 5, 2013	Z-1171-2013	—	terminated	Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.
Aug 3, 2012	Z-2250-2012	—	terminated	May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
Sep 20, 2010	Z-2406-2011	—	terminated	The recall was initiated because Newport Medical has confirmed a limited number of power cords recently received from their supplier, Glob-Tek, have a slightly oversized plug connector which prevents the cord from locking into place. These cords are fully functional as supplied. However, the cord can be easily disconnected. If the cord is disconnected, the HT70 will alert the user with a power di
May 14, 2010	Z-2382-2011	—	terminated	The recall was initiated because Newport Medical has confirmed that the Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time.
Apr 14, 2010	Z-1617-2010	—	terminated	The recall was initiated due to a recent increase in complaints related to the early failure of a low pressure transducer which is on Printed Circuit Board (PCB) 2104A in the Newport e360 ventilator. Ventilators manufactured between September and December 2009 are affected by this field correction. All affected ventilators require the replacement of the PCB2104A board to avoid early failure of t
Oct 27, 2009	Z-2468-2011	—	terminated	Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
Jul 22, 2009	Z-2384-2011	—	terminated	The recall was initiated because Newport Medical has confirmed that the HT50 Dual Pac Ventilator is not compatiable with the external battery pack (p/n BAT3300A) supplied with the previous single battery ventilator. The Dual Pac system has a slightly higher amperage draw than the single battery and as a result can cause the fuse in the external battery pack to blow making the battery inoperable.
Jan 13, 2009	Z-2295-2011	—	terminated	The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery.
Dec 15, 2008	Z-2029-2009	—	terminated	In December 2008, Newport initiated a field correction to upgrade e360 ventilators with software versions 3.0 or higher to software version 3.3. As a result of this upgrade, some customers experienced unexpected device alert alarms. Newport's investigation into these complaints confirmed that the 3.3 software responds too quickly to certain situations, giving a false device alert. Newport condu
Jul 31, 2007	Z-1192-2007	—	terminated	Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not lasting as long as expected followed by ventilator shut down with less advance warning than when the battery was new.
Oct 29, 2005	Z-1375-05	—	terminated	Lack of alarm prior to shutdown.