FDA.reportPublic FDA data

alegriaCare

Primary DI
04260505370107
Brand
alegriaCare
Company
Wuxi Jiajian Medical Instrument Co.,Ltd.
Model
50*100
Device description
Flexible and easy to fit electrode can be applied to every contour of the human body. You can use the electrodes many times because of its reliable lo
Published
2017-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260505370107PrimaryGS10
34260505370107Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260505370107042605053701074260505370107
3426050537010734260505370107

GMDN Terms

TermDefinition
Electrical probe/electrode conductive padA small, non-sterile device designed to facilitate electrical conduction between an electrical stimulation probe or electrode and the skin. It is typically contoured to fit on a particular type of probe/electrode and is made of an absorbent material (e.g., felt) that may be soaked in a conduction fluid. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
529966489
Device count
4
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

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06972011718431JIAJIANCMNS6-22026-03-03
00815005021253SHUNLI0.30*502016-10-25
00815005021307SHUNLI0.16*152016-10-25
00815005021314SHUNLI0.20*152016-10-25
00815005021505Jiajianpointoselect2018-05-17
00815005021512SHUNLI0.20*302016-10-21
00815005021529SHUNLI0.25*302017-11-13
00815005021536SHUNLI0.16*302016-10-21
00815005021703ACE0.18*402017-08-29
00815005021765ACE0.18*132017-08-29
00815005021772ACE0.20*252017-08-29
00815005021789ACE0.16*132017-08-29

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