FDA.report

MediMax Tech

Primary DI
30817325020573
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
CF75R Tens Electrode
Device description
CF75R Tens Electrode - Standard Foam 75mm Round Stimulating Electrodes
Published
2016-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
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
10817325020579PackageGS110In Commercial Distribution
20817325020576PackageGS110In Commercial Distribution
30817325020573PackageGS15In Commercial Distribution
00817325020572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081732502057910817325020579
2081732502057620817325020576
3081732502057330817325020573
00817325020572008173250205728173250205720817325020572

GMDN Terms

TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
855-633-4629Malorie.c@medimaxtech.com

Regulatory Flags

DUNS number
927071162
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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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