FDA.reportPublic FDA data

Unimom

Primary DI
08809224872224
Brand
Unimom
Company
UNIMOM CO.
Model
Breast Shield Kit SE (Extra Large)
Device description
Unimom accessory(30mm shield set)
Published
2018-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
08809224872224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809224872224088092248722248809224872224

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, reusableA collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter30Millimeter

Contacts#

Phone, Email table
PhoneEmail
+827087985577infounimom@naver.com

Regulatory Flags#

DUNS number
689057658
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809224872460UnimomOpera+2021-11-05
08809224872408UnimomMinuet LCD+2021-09-14
08809224872415UnimomDetachable Breast Shield Kit (20mm)2021-09-14
08809224872422UnimomDetachable Breast Shield Kit (24mm)2021-09-14
08809224872439UnimomDetachable Breast Shield Kit (28mm)2021-09-14
08809224872446UnimomDetachable Breast Shield Kit (32mm)2021-09-14
08809224872262UnimomOpera2019-10-04
08809224872279UnimomOpera eco2019-10-04
08809224871289UnimomBreast Shield (24mm)2019-01-18
08809224871364UnimomBreast Shield (27mm)2019-01-18
08809224872217UnimomBreast Shield (30mm)2019-01-18
08809224871135UnimomMezzo#2018-12-13
08809224872026UnimomBreast Shield Kit SE (Regular)2018-12-13
08809224872088UnimomBreast Shield Kit SE (Large)2018-12-13
08809224872019UnimomMinuet LCD2018-08-23

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Primary DI, Brand, Company table
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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
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