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
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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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