FDA.reportPublic FDA data

momcozy

Primary DI
06975740360551
Brand
momcozy
Company
Shenzhen Root Innovation Technology Co., Ltd.
Model
S9 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
2023-02-17
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975740369172PackageGS127Not in Commercial Distribution
06975740369189PackageGS118Not in Commercial Distribution
06975740360551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975740369172069757403691726975740369172
06975740369189069757403691896975740369189
06975740360551069757403605516975740360551

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
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
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
06975740363071MomcozyBP420- Red2026-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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