FDA.reportPublic FDA data

Momcozy

Primary DI
06975740363071
Brand
Momcozy
Company
Shenzhen Root Innovation Technology Co., Ltd.
Model
BP420- Red
Device description
Momcozy Wearable Breast Pumps.
Published
2026-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K253283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253283000Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)Shenzhen Root Innovation Technology Co., Ltd.2025-10-29HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975740363071PrimaryGS10
96975740363050Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975740363071069757403630716975740363071
9697574036305096975740363050

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
411899033
Device count
2
Serial number
true
Manufacturing 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
00810104131018Willow Sync 5oz Container SetWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131025Willow Sync Container Back ReplacementWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131032Willow Sync Duckbill ValvesWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131049Willow Sync DiaphragmsWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131056Willow Sync 24mm FlangesWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131063Willow Sync Tubing AssemblyWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131087Willow Sync Receiver ReplacementWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131094Willow Sync Replacement PumpWILLOW INNOVATIONS, INC.HGX2026-07-16
00879388005132Rumble TuffA Cute Baby IncHGX2026-07-05
06935883910013Figaroo™ GoFlowHuizhou LVB Maternal & Infant Supplies Co., Ltd.HGX2026-07-03
06951727603019Figaroo™ EnduraShenzhen Changkun Technology Co., Ltd.HGX2026-06-26
06951727603033Figaroo™ DashShenzhen Changkun Technology Co., Ltd.HGX2026-06-26
26973493590991Figaroo™ElevateShenzhen TPH Technology Co., LtdHGX2026-06-22
26973493592834Figaroo™ EaseShenzhen TPH Technology Co., LtdHGX2026-06-22
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