Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011200334

FEI Number

3011200334

Entity Name

CARDINAL HEALTH

City/State/Country

Riverview, FL, US

Establishment Address

8322 Eagle Palm Drive, Riverview, FL 33578, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Cardinal Health 200, LLC (Owner Number: 9028292)

Owner / Operator Contact Address

3651 Birchwood Drive, --, Waukegan, IL 60085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2017-04-04
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2018-07-27
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-05-05
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2018-07-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-05-05
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-08-17
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2023-01-24
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2001-08-31
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-07-27
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2026-02-20
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2017-01-05
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2018-07-27
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-05-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-07-27
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2022-05-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cardinal Health 200, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004839227	Cardinal Health Malta 212 Ltd	Marsa, MT
3015541720	Cardinal Health Germany Manufacturing GmbH	Halberstadt Saxony-Anhalt, DE
1033903	Cardinal Health	Greenwood, SC, US
9611018	Cardinal Health Ireland Manufacturing Limited	TULLAMORE Offaly, IE
8040459	Kendall-Gammatron Limited	SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
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

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-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

Similar Registrations

Registration Number	Establishment Name	Location
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3020703724	Therma Bright Inc.	Toronto Ontario, CA
3014491159	AIROS MEDICAL INC	Audubon, PA, US
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3009155917	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011200334. Last updated year: 2026. Please use registration number 3011200334 when referencing this establishment in official correspondence.