FDA.report

Mamapro

Primary DI
00850083182007
Brand
Mamapro
Company
Interfocus Inc.
Model
H03
Device description
Electric Breast Pump
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
HGXPump, Breast, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K252342000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K252342000Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)Guangdong Youmeng Electrical Technology Co., Ltd.2025-12-19HGX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850083182007PrimaryGS10
00085008318203Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083182007008500831820078500831820070850083182007
00085008318203000850083182030850083182030085008318203

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
118935896
Device count
2
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
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04897152760045eufy Wearable Breast Pump S1 ProAnker Innovations LimitedHGX2026-03-14
04897152760052eufy Wearable Breast Pump E10Anker Innovations LimitedHGX2026-03-14
04897152760069eufy Wearable Breast Pump E20Anker Innovations LimitedHGX2026-03-14
04897152760038eufy Wearable Breast Pump S1Anker Innovations LimitedHGX2026-03-13
39551028430000AmedaTPH TECHNOLOGY MALAYSIA SDN. BHD.HGX2026-03-03
07640108054982Ardo MeliaArdo medical AGHGX2026-02-27
28809108019916SpectraUZINMEDICARE CO.,LTDHGX2026-02-27
26973493597341TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
26973493599437TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493598419AmedaShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592223MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592438lansinoh Shenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592537MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493593992MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493594241MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493594371MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493597075MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493597990MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493598232MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493598348MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493599369MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
00020451904566Motion InBra™Medela LLCHGX2026-02-16
00020451904573Motion InBra™Medela LLCHGX2026-02-16
00810178887170ViveVIVE HEALTH LLCHGX2026-02-09
28809108019688SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019695SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019701SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019718SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019763SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019770SpectraUZINMEDICARE CO.,LTDHGX2026-02-03