FDA.reportPublic FDA data

TensCare

Primary DI
05033435136490
Brand
TensCare
Company
TENSCARE LIMITED
Model
Nouri Auto
Catalog number
K00146
Device description
The Nouri Digital Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
Published
2022-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192640000Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast PumpGuangzhou Yongyi Industrial Co., Ltd.2020-03-30HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05033435136490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033435136490050334351364905033435136490

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, electricA mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
569403736
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05033435134403TensCareKegel Fit 2K-KEGEL22024-11-18
05033435138777TensCareCool Relief Electrodes 50X50E-CR50502024-11-06
05033435138784TensCareCool Relief Electrodes 50X100E-CR501002024-11-06
05033435139118TensCareHypoallergenic ElectrodesE-TRBG2024-11-06
05033435139132TensCareCarbon Mesh Electrode pads 50X50 mmE-TR50502024-11-06
05033435139156TensCareCarbon Mesh Electrode pads 50X100 mmE-TR501002024-11-06
05033435139705TensCareBack ElectrodeE-TRALBA2024-11-06
05033435139712TensCareKnee ElectrodeK-TRALKN2024-11-06
05033435139729TensCareNeck ElectrodeE-TRALNE2024-11-06
05033435136933TensCareForm Duo2024-07-25
05033435138920TensCareOva3K-OVA32024-07-24
05033435134090TensCareOva+K-OVAP-USA2024-01-16
05033435136209TensCareUnifitK-UNIFIT2023-11-03
05033435135646TensCareUnicareK-UNICARE2023-10-24
05033435133796TensCareShockwaveK-SHOCKWAVE2023-06-08
05033435120413TensCareKneeStimK-KNEE2023-09-01
05033435000722TensCareiGlove LargeK-GL-L2023-08-31
05033435000739TensCareiSock LargeK-SK-L2023-08-31
05033435070039TensCareiTouch SureK-ITS2023-08-31
05033435120239TensCareSports TENS 2K-ST22023-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055965Breast shell sterile DeTach 15 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)Ardo medical AGHGX2026-07-30
06925546002285ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546003381ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546033821ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06937266900017FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900024FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900031FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900048FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900055FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900062FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900079FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900086FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900093FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900109FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900116FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900123FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900130FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
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00810104131032Willow Sync Duckbill ValvesWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131049Willow Sync DiaphragmsWILLOW INNOVATIONS, INC.HGX2026-07-16