Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1915484

FEI Number

1915484

Entity Name

Cardinal Health

City/State/Country

Norfolk, NE, US

Establishment Address

1222 SHERWOOD RD., Norfolk, NE 68701, US

Establishment Type(s)

Manufacture 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

K771053

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
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-07-27
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2003-08-05
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-01-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2010-11-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-02-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-02-07
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2024-02-07
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2016-12-20
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2002-05-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-02-19
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2026-02-20
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2008-01-11
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-01-11
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2008-01-28
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2025-01-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2008-01-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-05
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-05
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-01-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-05
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2010-07-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-07-27
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2008-01-11
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2012-12-17
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2010-07-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-01-11
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2008-01-11

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
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-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1915484. Last updated year: 2026. Please use registration number 1915484 when referencing this establishment in official correspondence.