FDA.reportPublic FDA data

momcozy

Primary DI
06975740360452
Brand
momcozy
Company
Shenzhen Root Innovation Technology Co., Ltd.
Model
S10
Device description
The 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
Published
2022-12-01
Public version status
Update
Distribution status
Not 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
K220309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220309000Wearable Breast Pump (Model S10)Shenzhen Lutejiacheng Technology Co., Ltd.2022-06-27HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975740360452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975740360452069757403604526975740360452

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
411899033
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975740360186momcozy S12 Pro-white2023-01-01
06975740360193momcozy S9 Pro-grey-D2023-01-01
06975740360209momcozy S9 Pro-grey2023-01-01
06975740360216momcozy S12 Pro-white-D2023-01-01
06975740360421momcozy M5-Grey2023-01-01
06975740360438momcozy M5-Grey-D2023-01-01
06975740360469momcozy M5-Purple2023-02-10
06975740360476momcozy M5-burgundy2023-02-10
06975740360483momcozy M5-Green2023-02-10
06975740360490momcozy M5-Purple-D2023-02-10
06975740360506momcozy M5-burgundy-D2023-02-10
06975740360513momcozy M5-Green-D2023-02-10
06975740360551momcozy S9 Pro-pink2023-02-17
06975740360568momcozy S9 Pro-pink-D2023-02-17
06975740360582momcozy S9 Pro-purple2023-04-19
06975740360599momcozy S9 Pro-purple-D2023-04-19
06975740360612momcozy S12 Pro-Pink2023-04-19
06975740360629momcozy S12 Pro-Pink-D2023-04-19
06975740360728MomcozyBP1412023-08-21
06975740362371MomcozyBP380- Red D2026-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809444071049HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071056HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071223HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071230HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071339HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071346HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071353HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071360HaenimHaenim Co.,Ltd.HGX2026-06-05
06976313750014AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750021AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750212AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750229AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750236AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750649AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750656AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750663AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
08809108020017SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
08809108020024SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
19551028430006AmedaTPH TECHNOLOGY MALAYSIA SDN. BHD.HGX2026-03-03
07640108054975Ardo MeliaArdo medical AGHGX2026-02-27
08809108019912SpectraUZINMEDICARE CO.,LTDHGX2026-02-27
16973493597344TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493599430TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493592226MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493592431lansinoh Shenzhen TPH Technology Co., LtdHGX2026-02-25
16973493592530MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493593995MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493594244MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493594374MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493597078MommedShenzhen TPH Technology Co., LtdHGX2026-02-25