NextPhase Medical Devices, LLC

FDA Device Registration & Listing · MANSFIELD, MA, US · Registration 3003174284

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003174284
FEI Number
3003174284
Entity Name
NextPhase Medical Devices, LLC
City/State/Country
MANSFIELD, MA, US
Establishment Address
110 FORBES BLVD., MANSFIELD, MA 02048, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
NextPhase Medical Devices, LLC (Owner Number: 9050650)
Owner / Operator Contact Address
110 FORBES BLVD., --, Mansfield, MA 02048, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Prometra Codman OR Prep Kits CO2 Insufflator HTA Hysteroscope Adapter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LKK Pump, Infusion, Implanted, Programmable Unknown Class 3 N/A 2013-01-31
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-11-04
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2024-11-04
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2024-11-04
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2024-11-04
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2024-11-04
DQD Stethoscope, Electronic Cardiovascular Class 2 870.1875 2024-11-04
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2024-11-04
LKK Pump, Infusion, Implanted, Programmable Unknown Class 3 N/A 2021-09-07
FCX Insufflator, Automatic Carbon-Dioxide For Endoscope Gastroenterology, Urology Class 2 876.1500 2023-03-15
LOZ Artificial Heart Unknown Class 3 N/A 2014-12-20
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2024-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NextPhase Medical Devices, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0022-2007 Medtronic Neuromodulation 3
Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.
Z-0001-2015 Invivo Corporation 2
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023 Philips North America Llc 2
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04 GE Medical Systems Information Technologies 2
Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015 Mckesson Information Solutions LLC 2
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003174284. Last updated year: 2026. Please use registration number 3003174284 when referencing this establishment in official correspondence.
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