FDA.reportPublic FDA data

Konmed

Primary DI
06970935830246
Brand
Konmed
Company
Shenzhen Konmed Technology Co., Ltd.
Model
KM-W-40
Device description
It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, with adjustable size which will not affected by the size of your hands.
Published
2018-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LQXDevice, Finger-Sucking

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQXDevice, Finger-SuckingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970935830246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970935830246069709358302466970935830246

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544436531
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970935830635Pelvic Muscle TrainerKM516B2026-07-08
06970935830734Pelvic Muscle TrainerKM5102026-07-08
06970935830529KONMED /PelvifineKM508B2025-09-30
06970935830710PelvifineKM5002025-02-18
06970935830536KONMED /PelvifineKM5302021-10-25
06970935830543KONMED /PelvifineKM5312021-10-25
06970935830482KONMEDKM-5022024-03-05
06970935830499KONMEDKM-5032024-03-05
06970935830642KONMEDKM-5042024-03-05
06970935830659KONMEDKM-5052024-03-05
06970935830666KONMEDKM-5062024-03-05
06970935830673KONMEDKM-5072024-03-05
06970935830680KONMEDKM-50132024-03-05
06970935830697KONMEDKM-50182024-03-05
06970935830567KONMED /PelvifineKM530B2022-08-24
06970935830574KONMED /PelvifineKM531B2022-08-24
06970935830581KONMED /PelvifineKM5362022-08-24
06970935830598KONMED /PelvifineKM5372022-08-24
06970935830079KonmedKM-8032018-01-25
06970935830086KonmedKM-8082018-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970935830260KonmedShenzhen Konmed Technology Co., Ltd.LQX2018-01-24
06970935830277KonmedShenzhen Konmed Technology Co., Ltd.LQX2018-01-24