Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007499349

FEI Number

3011774813

Entity Name

VERIDIAN HEALTHCARE

City/State/Country

Gurnee, IL, US

Establishment Address

1175 Lakeside Dr, Gurnee, IL 60031, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Veridian Healthcare (Owner Number: 10028759)

Owner / Operator Contact Address

1175 Lakeside Drive, Gurnee, IL 60031, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092045

PMA Number

N/A

All Registered Proprietary Names

302-6110B Trackstar Infrared Forehead Thermometer with Rotating Head WS-380 ZEWA Premium Wrist BP Monitor, Bluetooth 01-508 SmartHeart Automatic Wrist Digital BP 302-WS380 Trackstar Premium Wrist BP Monitor, Bluetooth 01-745T SmartHeart Talking Wrist Blood Pressure Monitor 01-574 SmartHeart Wrist Blood Pressure Monitor 01-539 SmartHeart Auto Digital Blood Pressure Monitor 01-5811T SmartHeart Talking BP Monitor 01-539WR SmartHeart Auto Digital BP Monitor, Wide Range Cuff 01-573 SmartHeart Arm Blood Pressure Monitor 01-572 SmartHeart Automatic Arm Cuff Digital BP Unit 01-571 SmartHeart Premium Automatic Arm Digital BP Unit 01-550 SmartHeart Automatic Arm Digital BP 303-001 HELLO HEART SINGLE-CELL PILL BOX, BLUETOOTH,303-002 HELLO HEART MULTI-CELL PILL BOX, BLUETOOTH R.P.M. PRO BLOOD GLUCOSE TEST STRIPS 50-COUNT MODEL 210-7110TS R.P.M. PRO BLOOD GLUCOSE MONITORING KIT, BLUETOOTH MODEL 210-7110BK CIN 6134753 LEADER PULSE OXIMETER DELUXE PORTABLE Model 302-3110B Trackstar Bluetooth Pulse Oximeter 21600 Zewa Connect Bluetooth Pulse Oximeter CIN 6129324 LEADER PULSE OXIMETER PORTABLE Model 11-50Q1 Pediatric Pulse Oximeter Model 210-3110B R.P.M. PRO Bluetooth Pulse Oximeter Model YM402 Transtek Bluetooth Pulse Oximeter 01-556 SmartHeart Automatic Wrist Digital BP 19-030 Theracare Ultrasonic Oral Appliance Cover Guard R.P.M. PRO BLOOD GLUCOSE LANCETS MODEL 210-7110LC R.P.M. PRO BLOOD GLUCOSE LANCING DEVICE MODEL 210-7110LD 01-746T SmartHeart Talking Arm Blood Pressure Monitor 6134761 Leader Talking Blood Pressure Monitor with Wide Range Cuff UAM-880UA UAM-820BT Zewa Connect Upper Arm Bluetooth Blood Pressure Monitor UAM-880 ZEWA Bluetooth Blood Pressure Arm Monitor UAM-710 ZEWA Automatic Blood Pressure Monitor 01-540 SmartHeart Wrist Blood Pressure Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2026-06-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-05-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-05-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-17
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2025-08-27
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2026-03-19
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2025-09-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-17
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2026-06-10
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-08-11
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2026-03-12
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-03-19
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2026-03-19
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-03-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-06-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-09-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-17

Official Correspondent

Jeri Hill

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Veridian Healthcare

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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

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.
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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3010852191	HONG KONG MEDSOURCING LIMITED	KOWLOON, HK
3008573045	Andon Medical co., LTD	Tianjin, CN
3016670149	GUANGDONG GENIAL TECHNOLOGY CO., LTD.	Zhaoqing Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007499349. Last updated year: 2026. Please use registration number 3007499349 when referencing this establishment in official correspondence.