FDA.report

Elefix

Primary DI
00841983102882
Brand
Elefix
Company
NIHON KOHDEN AMERICA, INC.
Model
Z-181JE
Catalog number
Z-181JE
Device description
Elefix Electrode Adhesive, 180g tubes
Published
2016-09-19
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
GYBMEDIA, ELECTROCONDUCTIVE

Product Code Classifications

CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841983102882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983102882008419831028828419831028820841983102882

GMDN Terms

TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)325-0283info@nkusa.com

Regulatory Flags

DUNS number
021063219
Device count
1
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
false
Sterilization required before use
false

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