Cardinal Health

FDA Device Registration & Listing · DELAND, FL, US · Registration 1017768

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
1017768
FEI Number
1017768
Entity Name
Cardinal Health
City/State/Country
DELAND, FL, US
Establishment Address
2010 E International Speedway Blvd, DELAND, FL 32724, 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
N
Expiration Date (Year)
2026
510(k) Number
K960982
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
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2005-04-06
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2025-01-06
FMF Syringe, Piston General Hospital Class 2 880.5860 2010-11-11
FMF Syringe, Piston General Hospital Class 2 880.5860 2026-02-19
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 1977-12-23
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2005-04-13
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2008-01-16
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2007-04-20
OIB Blood And Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2011-11-09
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2009-10-27
DZM Needle, Dental Dental Class 1 872.4730 1977-12-23
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2007-12-05
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2007-12-05

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
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09
K203410 Shantou Wealy Medical Instrument Co.,Ltd ENFit Disposable Enteral Syringe 2021-06-28
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
K781371 Ferris Mfg. Corp. BONE MARROW ASPIRATION KIT 1978-09-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1017768. Last updated year: 2026. Please use registration number 1017768 when referencing this establishment in official correspondence.
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