FDA.report

Uni-Patch

Primary DI
90884521167908
Brand
Uni-Patch
Company
Cardinal Health, Inc.
Model
EP85825
Catalog number
EP85825
Device description
C Series Stimulating Electrodes,3160F, Carbon, 40 Gel
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GXYELECTRODE, CUTANEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
90884521167908PackageGS11000In Commercial Distribution
10884521167902PrimaryGS10
10884521537071Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
9088452116790890884521167908
1088452116790210884521167902
1088452153707110884521537071

GMDN Terms

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.

Device Sizes

TypeValueUnit
Outer Diameter2.75Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods

Method

Contacts

PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags

DUNS number
080935429
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

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20884521142760Monoject10884521142763108845211427632018-06-29
00029369211032MCDAVIDMH794002112023-05-26
90884521162088Uni-PatchMH73912MH739122018-06-30

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