Data / Medical devices / United States / NextPhase Medical Devices LLC

NextPhase Medical Devices LLC: FDA-registered device maker in Rochester, NH, United States, 7 510(k) clearances

Name: NextPhase Medical Devices LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

NextPhase Medical Devices LLC is registered with the FDA (registration 1225492) in Rochester, NH, United States. It lists 18 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 18, 2019. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1225492
FEI number: 3001237338
Address: 88 Airport Dr, Rochester, NH, United States, 03867
Owner or operator: NextPhase Medical Devices LLC (9026654)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: October 23, 2012
Registered through: 2027
Brand names listed: 23-113-1 BIPOLAR SEALER AQM 2.3, 23-121-1 BIPOLAR SEALER AQM EVS, 23-312-1 BIPOLAR SEALER AQM SBS 5, 23-314-1 BIPOLAR SEALER AQM MINI EVS3.4, 23-317-1 BIPOLAR SEALER AQM ENDO DBS 8.7, 23-320-1 BIPOLAR SEALER AQM ENDO VS8.7R VATS, 23-321-1 AQM MIS FLEX, 23-322-1 AQM MIS FLEX MINI and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Contract manufacturer	accessdata.fda.gov
Continuous, Ventilator, Home Use	NOU	2	Repackager or relabeler	accessdata.fda.gov
Culture, Intravaginal, Assisted Reproduction	OYO	2	Contract manufacturer	accessdata.fda.gov
Ear, Nose, And Throat Stereotaxic Instrument	PGW	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Contract manufacturer	accessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	BZE	2	Repackager or relabeler	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Contract manufacturer	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Contract manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Contract manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Contract manufacturer	accessdata.fda.gov
Semi-Automated Autologous Skin Graft Harvesting And Application Device	QYK	2	Contract manufacturer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 18, 2019	K181170	Trilogy Evo Universal	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
July 18, 2019	K181166	Trilogy Evo	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
March 5, 2015	K143646	MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
December 6, 2012	K122432	ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS	BZE	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
April 16, 2012	K103767	DUAL HEATED INFANT VREATHING CIROUITS	BZE	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
November 10, 1998	K983112	RESPIRATORY HUMIDIFIER, MODEL # MR850	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 30, 1998	K972992	CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS	CCL	Substantially Equivalent	Ceramatec, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 18, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.