Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010405299

FEI Number

3010405299

Entity Name

Kaz USA, Inc., A Helen of Troy Company

City/State/Country

Olive Branch, MS, US

Establishment Address

7159 Polk Lane, Olive Branch, MS 38654, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Kaz USA, Inc., A Helen of Troy Company (Owner Number: 1314800)

Owner / Operator Contact Address

400 Donald Lynch Boulevard, Suite 300, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103839

PMA Number

N/A

All Registered Proprietary Names

Vicks Braun Thermoscan BRAUN ExactFit 1 Upper arm blood pressure monitor VICKS NO TOUCH THERMOMETER BRAUN NO TOUCH THERMOMETER Vicks, Instant Digital Electric Thermometer Vick ComfortFlex Thermometer Vicks Digital Thermometer Braun Digital Thermometer Vicks Braun Thermoscan Braun Thermoscan Vicks Honeywell Braun Thermoscan PRO 4000 series Braun Thermoscan IRT 4000 series Braun Thermoscan VICKS NON CONTACT INFRARED BODY THERMOMETER Braun ThermoScan 3 High Speed Compact Ear Thermometer Braun Precision Sensor Braun No Touch + Forehead Thermometer Braun No touch 3-in-1 Thermometer BRAUN Sensian 4 3-in-1 Thermometer Therasteam Personal Steam Inhaler QuietCare® Cool Moisture Humidifier Easy to Care Top Fill Warm Mist Humidifier Top Fill Ultrasonic Humidifier Filter Free Cool Moisture Humidifier Ultrasonic Cool Mist Humidifier Warm Mist Humidifier UltraViolet Germ-Free Humidification UltraViolet Germ-Free Cool Moisture Humidifier Top Fill Warm Mist Humidifier MistMate Cool Mist Humidifier Easy to Care Filter Free Humidifier Cool Moisture Humidifier Filter Free Cool Mist Humidifier UltraViolet Germ-Free Cool Mist Humidifier Easy to Care Top Fill Cool Moisture Humidifier CVS Health Warm Mist Humidifier Rite Aid Ultasonic Cool Mist Humidifier Honeywell Easy to Care Cool Moisture Humidifier Vicks NaturalCare Humidifier Diffuser VapoPads Nitetime-Light CVS Health Cool Mist Humidifier Honeywell Easy to Care Cool Mist Humidifier CVS Health Warm Steam Vaporizer Vicks Mini FilterFree Cool Mist Humidifier Vicks 3-in-1 SleepyTime Humidifier Honeywell Reflection Cool Mist Filter Free Humidifier Braun ExactFit 1E Upper Arm Blood Pressure Monitor Braun ExactFit 1E Braun ExactFit 2 Braun BRAUN ExactFit 2 connect Upper arm Blood pressure monitor BRAUN EXACTFIT 3 UPPER ARM BLOOD PRESSURE MONITOR BRAUN Thermometer Braun Infrared Forehead Thermometer Vicks Underarm Thermometer Braun Braun ThermoScan Infrared Ear Thermometer IRT6525AP Braun ThermoScan Infrared Ear Thermometer IRT6030AP Braun ThermoScan Infrared Ear Thermometer IRT6525 Thermometer Thermometer with Charge Dock Braun Probe Covers Welch Allyn Thermometer Charge Dock Only 9' Tether for PRO6000 Therm w/ small cradle 4th Ed Rechargeable Battery PRO6000 6' Tether for PRO 6000 PRO6000 w/Small Cradle & Charging Dock Braun Thermoscan Pro 6000 Pro6000 Bulk Pack 4th ed Therm w/ large cradle 4th ed PRO6000 Large Cradle PRO6000 Small Cradle PRO6000 Bulk Pack PRO6000 Charge Station (US) PRO6000 Charge Station PRO 6000 CHARGE DOCK Therm w/ small cradle Them w/ large cradle Battery Door Vicks Braun

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-06-17
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2021-12-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2015-11-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-06-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-06-17
FRF	Cleaner, Air, Medical Recirculating	General Hospital	Class 2	880.5045	2007-11-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-01-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-03-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-07-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2008-06-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-07-30
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2007-11-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-04-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-01-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-06-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-05-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-11-16
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-07-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-04-13
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-08-18
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2026-06-16
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-05-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kaz USA, Inc., A Helen of Troy Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006169981	Kaz USA, Inc., A Helen of Troy Company	MARLBOROUGH, MA, US
3004871905	Helen of Troy Macao Limited	Macau Guangdong, CN

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-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010405299. Last updated year: 2026. Please use registration number 3010405299 when referencing this establishment in official correspondence.