FDA.report

Uni-Patch

Primary DI
90884521168271
Brand
Uni-Patch
Company
Cardinal Health, Inc.
Model
EP84159
Catalog number
EP84159
Device description
S Series Stimulating Electrodes,2204, Silver Carbon, Aloe Vera 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
DRXElectrode, electrocardiograph

Product Code Classifications

CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
90884521168271PackageGS11200In Commercial Distribution
10884521168275PrimaryGS10
10884521536210Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
9088452116827190884521168271
1088452116827510884521168275
1088452153621010884521536210

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
Length2Inch
Width2Inch

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
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

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