FDA.reportPublic FDA data

Medela

Primary DI
86978342980086
Brand
Medela
Company
Guangdong Youmeng Electrical Technology Co., Ltd.
Model
Melody InBra YM-8803
Device description
Wearable electric breast pump
Published
2025-12-31
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
false

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
K252754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252754000Wearable Electric Breast Pump (YM-8803)Guangdong Youmeng Electrical Technology Co., Ltd.2025-12-19HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00020451904184PackageGS11In Commercial Distribution
00020451904498PackageGS11In Commercial Distribution
06978342980080PrimaryGS10
86978342980086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00020451904184000204519041840204519041840020451904184
00020451904498000204519044980204519044980020451904498
06978342980080069783429800806978342980080
8697834298008686978342980086

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
714437286
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
false
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
06978342980196Youmeng ElectricalYM-81662026-04-21
06978342980172MedelaMelody InBra YM-88032026-04-01
00020451905389MedelaMelody InBra Resupply Kit2026-03-20
06978342980080MedelaMelody InBra YM-88032025-12-31

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