FDA.report

Medline

Primary DI
30193489036309
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDSE2X35CA
Catalog number
MDSE2X35CA
Device description
ELECTRODES,TENS,ADVANTAGE,CLOTH, 2X3.5
Published
2022-12-01
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

Related Records

Contact Domains

Product Codes

CodeName
GXYElectrode, cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30193489036309PackageGS110In Commercial Distribution
20193489036302PrimaryGS10
00193489036308Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3019348903630930193489036309
2019348903630220193489036302
00193489036308001934890363081934890363080193489036308

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry, Protect from freezing, Avoid excessive heat.
Special Storage Condition, Specify00Keep Dry, Protect from freezing, Avoid excessive heat. Store electrodes in a sealed bag, in a cool, dry location.
Special Storage Condition, Specify00Store in a cool, dry place.
Storage Environment Temperature5 Degrees Celsius27 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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