FDA.reportPublic FDA data

Friendship Medical

Primary DI
16955739020106
Brand
Friendship Medical
Company
Xi'an Friendship Medical Electronics Co.,Ltd.
Model
SEAg-S-2500/35×50
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110289000FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODEXian Friendship Medical Electronics Co., Ltd.2011-08-30GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26955739020103PackageGS124In Commercial Distribution
16955739020106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2695573902010326955739020103
1695573902010616955739020106

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
529249095
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16955739010329Friendship MedicalNE-T-2000/17/0.402024-05-10
26955739010326Friendship MedicalNE-T-2000/17/0.402024-05-10
16955739012385Friendship MedicalNE-T-1500/13/0.4-GP22023-12-15
26955739012382Friendship MedicalNE-T-1500/13/0.4-GP22023-12-15
16955739012392Friendship MedicalNE-P-2500/13/0.4-GP22023-12-01
26955739012399Friendship MedicalNE-P-2500/13/0.4-GP22023-12-01
16955739012224Friendship MedicalNE-T-2500/18/0.42023-05-05
16955739012316Friendship MedicalNE-D1-2500/18/0.42023-06-27
26955739012313Friendship MedicalNE-D1-2500/18/0.42023-06-27
26955739012221Friendship MedicalNE-T-2500/18/0.42023-05-05
16955739012149Cadwell302822-000-060-GP22023-02-28
16955739012156Cadwell302822-000-100-GP22023-02-28
26955739012146Cadwell302822-000-060-GP22023-02-28
26955739012153Cadwell302822-000-100-GP22023-02-28
16955739000047Cadwell302852-000-0602022-04-29
16955739000054Cadwell302852-000-1002022-04-29
16955739000061Cadwell302853-000-0602022-04-29
16955739000078Cadwell302853-000-1002022-04-29
16955739000085Cadwell302854-000-0602022-04-29
16955739000092Cadwell302854-000-1002022-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02