FDA.reportPublic FDA data

momcozy

Primary DI
06975740369257
Brand
momcozy
Company
Shenzhen Lutejiacheng Technology Co., Ltd.
Model
S12 Pro-Pink
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
2023-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K230776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220309000Wearable Breast Pump (Model S10)Shenzhen Lutejiacheng Technology Co., Ltd.2022-06-27HGX
K230776000Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)Shenzhen Lutejiacheng Technology Co., Ltd.2023-06-09HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975740369257PackageGS127In Commercial Distribution
06975740369264PackageGS118In Commercial Distribution
06975740360612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975740369257069757403692576975740369257
06975740369264069757403692646975740369264
06975740360612069757403606126975740360612

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
96975740362374MomcozyBP380- Red D2026-01-10
96975740363050MomcozyBP420- Red2026-01-10
06975740369721MomcozyBP1412023-08-21
06975740369219momcozy S9 Pro-purple2023-04-19
06975740369233momcozy S9 Pro-purple-D2023-04-19
06975740369271momcozy S12 Pro-Pink-D2023-04-19
06975740369172momcozy S9 Pro-pink2023-02-17
06975740369196momcozy S9 Pro-pink-D2023-02-17
06975740369059momcozy S12 Pro-white2023-01-01
06975740369035momcozy S9 Pro-grey-D2023-01-01
06975740369011momcozy S9 Pro-grey2023-01-01
06975740369073momcozy S12 Pro-white-D2023-01-01
06975740369158momcozy M5-Purple2023-02-10
06975740369141momcozy M5-burgundy2023-02-10
06975740369110momcozy M5-Green2023-02-10
06975740369165momcozy M5-Purple-D2023-02-10
06975740369134momcozy M5-burgundy-D2023-02-10
06975740369127momcozy M5-Green-D2023-02-10
06975740369103momcozy M5-Grey2023-01-01
06975740369097momcozy M5-Grey-D2023-01-01

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