FDA.reportPublic FDA data

Zimeitu

Primary DI
06925546002285
Brand
Zimeitu
Company
Cixi Ruihong Electric Appliance Co., Ltd.
Model
RH228
Device description
The electric breast pump is a single patient reusable device, which intended to be used by lactating women to express and collect milk from their breasts. A diaphragm-type vacuum pump driven by a microprocessor, the microprocessor provides control over vacuum pressure and cycle speed.
Published
2026-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
K201903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201903000Electric breast pump (Models: RH-228 and RH-338)Cixi Ruihong Electric Appliance Co., Ltd.2021-04-09HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06925546002285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06925546002285069255460022856925546002285

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
526967198
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
06925546001882ZimeituRH1182026-07-28
06925546001981ZimeituRH1982026-07-28
06925546003381ZimeituRH3382026-07-28
06925546020814ZimeituRH2082026-07-28
06925546033821ZimeituRH338A2026-07-28
06925546002087Figaroo™ GlideRH2082026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06925546003381ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546033821ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06937266900017FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900024FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900031FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900048FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900055FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900062FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900079FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900086FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900093FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900109FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900116FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900123FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900130FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
00020451906065Pump In Style Pro+ w/HarmonyMedela LLCHGX2026-07-20
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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