FDA.reportPublic FDA data

DR -HOS

Primary DI
06970742221671
Brand
DR -HOS
Company
Guangzhou Xinbo Electronic Co., Ltd.
Model
DHGEL
Device description
Conductive Electrode Gel: a conductive medium for use on fabric or metal electrodes
Published
2021-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
GYBMedia, Electroconductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200402000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200402000DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd.2020-11-25GYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970742221671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970742221671069707422216716970742221671

GMDN Terms#

Term, Definition table
TermDefinition
Mediastinal drainage catheter, non-antimicrobialA tube designed to establish a channel for the removal of fluid or purulent material from the mediastinum (the central compartment of the thoracic cavity); it is not coated with an antimicrobial agent. It is typically used in conjunction with, or as a component of, a drainage system that uses a low negative pressure through the drain lumen. It is typically made of silicone, available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction; it does not include any fluid collection bags/containers. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530683813
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970742220339DR-HOSMotionciser2025-06-30
06970742220278DR-HOSDHP-King2023-11-12
06970742220285DR-HOSDHP-Queen2023-11-12
06970742220292DR-HOSDHP-Children2023-11-12
06970742220308DR-HOSDHP-Travel2023-11-12
06970742220315DR-HOSDHP-Leg2023-11-12
06970742221770DR -HOSDH-CP-I2022-01-07
06970742221787DR -HOSDH-P.T.S-I2022-01-07
06970742221794DR -HOSDH-P.T.S-II2022-01-07
06970742221800DR -HOSDH-P.T.S-IIA2022-01-07
06970742221817DR -HOSDH-P.T.S-IIB2022-01-07
06970742221824DR -HOSP.T.S-III2022-01-07
06970742221411DR-HO'SCP-I2020-03-01
06970742221428Equate P.T.S-II2020-03-01
06970742221435DR-HO'SP.T.S- II B2020-03-01
06970742221442DR-HO'SP.T.S-II A2020-03-01
06970742221459DR-HO'SP.T.S-II2020-03-01
06970742221732DR -HOSNN-KN-Blue2021-09-01
06970742221725DR -HOSNN-CA-Blue2021-09-01
06970742221749DR -HOSNN-AN-Blue2021-09-01

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