FDA.reportPublic FDA data

Rochester

Primary DI
10816843022669
Brand
Rochester
Company
ROCHESTER ELECTRO-MEDICAL, INC.
Model
701505-P
Device description
ROCHESTER ELECTRODE JELLY: ORIGINAL SALT JELLY FORMULA
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GYBMedia, Electroconductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816843022669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081684302266910816843022669

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.

Contacts#

Phone, Email table
PhoneEmail
18003285544info@rochestermed.com

Regulatory Flags#

DUNS number
068156330
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816843021235Rochester2220002016-09-24
10816843021259Rochester2221112016-09-24
10816843021273Rochester2224662016-09-24
10816843020009Rochester0322382016-09-24
10816843020023Rochester0325432016-09-24
10816843020047Rochester0356872016-09-24
10816843020061Rochester0356892016-09-24
10816843020085Rochester0383752016-09-24
10816843023741Rochester2220002016-09-24
10816843023765Rochester2221112016-09-24
10816843021297Rochester2224662016-09-24
10816843020276EverLast™BMS017T15-42016-09-24
10816843020290EverLast™BMS037T15-102016-09-24
10816843020313EverLast™BMS037T15-42016-09-24
10816843020337EverLast™BMS037T15-52016-09-24
10816843020351EverLast™BMS037T15-62016-09-24
10816843020375EverLast™BMS037T15-82016-09-24
10816843020399UltraLast™BMS042T15-42016-09-24
10816843020412UltraLast™BMS042T15-52016-09-24
10816843020436UltraLast™BMS042T15-62016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09342451003416Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003423Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003430Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003447Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
00197998355363Solventum™Solventum US LLCGYB2026-02-15
00197998355400Solventum™Solventum US LLCGYB2026-02-15
00197998355370Solventum™Solventum US LLCGYB2026-02-15
00197998355417Solventum™Solventum US LLCGYB2026-02-15
06973602730795FyneLookTOP-RANK HEALTH CARE CO., LTD.GYB2025-10-23
06974667824986JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
06974667824993JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
06974667825006JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
16974667824983JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
16974667824990JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
16974667825003JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
06973602730627MedvatTOP-RANK HEALTH CARE CO., LTD.GYB2025-04-23
06973602730610MedvatTOP-RANK HEALTH CARE CO., LTD.GYB2025-03-18
00850024089235MedvatMyt Enterprises LLCGYB2025-02-19
00840295408224TherabodyTherabody, Inc.GYB2025-01-26
B1870800TheraMistNEUROTRON MEDICAL, INC.GYB2024-12-04
06971292004011AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-29
16971292006739AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
16971292006746AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
26971292006736AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
26971292006743AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
04260280180335AxionAxion USA LLCGYB2024-03-18
04262356159993EEG-acpCNSAC Medshop GmbHGYB2024-01-22
B311PEHTNPDS20PURE ENRICHMENTBEAR DOWN CONSULTINGGYB2023-12-14
B311PEHTNPDS50PURE ENRICHMENTBEAR DOWN CONSULTINGGYB2023-12-14
00850021097561Nu Skin RenuSpa iO PackageNSE PRODUCTS, INC.GYB2023-11-27