FDA.reportPublic FDA data

momcozy

Primary DI
06975983270037
Brand
momcozy
Company
Shenzhen Lutejiacheng Supply Chain Management Co., Ltd.
Model
S9-D
Device description
The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Published
2023-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K220596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220596000Wearable Breast Pump (Model S9)Shenzhen TPH Technology Co., Ltd.2022-05-26HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975983270051PackageGS16In Commercial Distribution
06975983270037PrimaryGS10
06975983270044Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975983270051069759832700516975983270051
06975983270037069759832700376975983270037
06975983270044069759832700446975983270044

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.

Regulatory Flags#

DUNS number
615691114
Device count
2
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975983272482MomcozyBF007_8pcs2024-05-21
06975983272499MomcozyBF007_16pcs2024-05-21
06975983272017MomcozyBF008_2PC2023-11-08
06975983272024MomcozyBF007_4PC2023-11-08
06975983272505MomcozyBF009_12PC2024-05-23
06975983272512MomcozyBF009_20PC2024-05-23
06975983272420MomcozyNS005_45mm2024-05-21
06975983272437MomcozyNS005_55mm2024-05-21
06975983272444MomcozyNS005_65mm2024-05-21
06975983272451MomcozyNS-001_17mm 2024-05-21
06975983272468MomcozyNS-001_20mm 2024-05-21
06975983272475MomcozyNS-001_24mm 2024-05-21
06975983272390MomcozyB01_Size 5_48pc2024-05-17
06975983272406BabycozyB01_Size 4_52pc_2bags2024-05-17
06975983272413BabycozyB01_Size 5_44pc_2bags2024-05-17
06975983273021MomcozyBN0052024-01-10
06975983273120MomcozyBN0052024-01-10
06975983272352MomcozyBY001_Pink+Green2024-04-23
06975983272369MomcozyBY001_Yellow+Blue2024-04-23
06975983272376BabycozyB04_3T-4T_68pc2024-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975740363477MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363484MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363750MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363767MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
00850000125506Primo PassiPrimo Passi LLCHGX2026-09-19
09420060218022haakaaTHINK GREEN LIMITEDHGX2026-09-18
09420060218053haakaaTHINK GREEN LIMITEDHGX2026-09-18
04897152760014eufy Wearable Breast PumpAnker Innovations LimitedHGX2026-08-21
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