Cardinal Health

FDA Device Registration & Listing · Wabasha, MN, US · Registration 2183164

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
2183164
FEI Number
1000116809
Entity Name
Cardinal Health
City/State/Country
Wabasha, MN, US
Establishment Address
1313 WEST GRANT BLVD., Wabasha, MN 55981, 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
K871222
PMA Number
N/A

All Registered Proprietary Names

AMPCARE E Series Electrodes

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10
EGJ Device, Iontophoresis, Other Uses Physical Medicine Class 2 890.5525 2008-11-20
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2010-02-03
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2008-01-10
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2012-11-28
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2016-12-05
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2019-04-18
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2014-12-04
FQM Bandage, Elastic General Hospital Class 1 880.5075 2007-04-26
QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology Class 3 876.5270 2012-11-30
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2001-08-31
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2014-05-14
NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence Gastroenterology, Urology Class 2 876.5310 2013-07-09
NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief Neurology Class 2 882.5890 2019-03-14
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2019-03-14
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10

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
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

Similar Registrations

Registration Number Establishment Name Location
3015614098 CGX, LLC San Diego, CA, US
3015429360 SHAOXING YINGTUO HEALTHCARE CO.,LTD. Shaoxing Zhejiang, CN
3004695199 INCEREB LTD Dublin Dun Laoghaire-Rathdown, IE
3005581220 SPES MEDICA S.P.A BATTIPAGLIA Salerno, IT
9616086 DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. TIJUANA Baja California, MX
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183164. Last updated year: 2026. Please use registration number 2183164 when referencing this establishment in official correspondence.
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