FDA.reportPublic FDA data

Uni-Patch

Primary DI
10192253018370
Brand
Uni-Patch
Company
Cardinal Health 200, LLC
Model
697SS
Catalog number
EP85215
Device description
Uni-Patch™ S Series Stimulating Electrodes
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, nerve, transcutaneous, for pain relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90192253018376PackageGS11In Commercial Distribution
20192253018377PrimaryGS10
10192253018370Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9019225301837690192253018376
2019225301837720192253018377
1019225301837010192253018370

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975869140041/Dongguan Bohuikang Technology Co., Ltd.GZJ2026-03-05
06932307410432JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.GZJ2026-03-04
06932307410425JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.GZJ2026-03-03
08032625824480GLOBUSDOMINO SRLGZJ2026-02-23
00714905117649Fab StimCOMPASS HEALTH BRANDS CORP.GZJ2026-02-06
00860163000312CMS COMPASS HEALTH BRANDS CORP.GZJ2026-02-06
00810178880799ViveVIVE HEALTH LLCGZJ2026-02-05
16971712720139KINGPAVONINIHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-01-30
06971760281357EmeTermWAT Medical Technology Inc.GZJ2026-01-23
00092237621967TwinStimCOMPASS HEALTH BRANDS CORP.GZJ2025-09-29
00860011592808Protocol SolutionsProtocol Solutions LLCGZJ2025-09-05
16971760280050EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280067EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280074EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280081EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280098EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280104EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760281125EmeTermWAT Medical Technology Inc.GZJ2025-08-22
00092237621974TwinStimCOMPASS HEALTH BRANDS CORP.GZJ2025-08-15
06971760280251EmeTermWAT Medical Technology Inc.GZJ2025-07-31
16971760281071EmeTermWAT Medical Technology Inc.GZJ2025-07-31
00850070096003STIMPOD NMS460ALGIAMED TECHNOLOGIES USA INC.GZJ2025-05-06
00850070096010STIMPOD NMS460 KitALGIAMED TECHNOLOGIES USA INC.GZJ2025-05-06
00850070096027Pulsed Radio Frequency Nerve Stimulation CableALGIAMED TECHNOLOGIES USA INC.GZJ2025-05-06
30661168800010Reliefband® Sport - BlackRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
30661168800027Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
10661168000164Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000174Reliefband® FlexRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
10661168000188Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
08720618311139Sonopuls 494Enraf-Nonius B.V.GZJ2025-02-11