FDA.reportPublic FDA data

Cadwell

Primary DI
26955739000013
Brand
Cadwell
Company
Xi'an Friendship Medical Electronics Co.,Ltd.
Model
302850-000-080
Published
2022-04-24
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

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
26955739000013PackageGS124In Commercial Distribution
16955739000016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2695573900001326955739000013
1695573900001616955739000016

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529249095
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
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

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
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16