FDA.reportPublic FDA data

Unimom

Primary DI
08809224871135
Brand
Unimom
Company
UNIMOM CO.
Model
Mezzo#
Device description
Manual Breast Pump
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
HGYPump, Breast, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGYPump, Breast, Non-PoweredObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809224871135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809224871135088092248711358809224871135

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, manualA hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
689057658
Device count
1
Premarket exempt
true
Lot or batch
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
08809224872026UnimomBreast Shield Kit SE (Regular)2018-12-13
08809224872088UnimomBreast Shield Kit SE (Large)2018-12-13
08809224872224UnimomBreast Shield Kit SE (Extra Large)2018-12-13
08809224872019UnimomMinuet LCD2018-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09420060215090haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215106haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215113haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215120haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215137haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060216011haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060216028haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060216035haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060214123haakaaTHINK GREEN LIMITEDHGY2026-09-20
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09420060214154haakaaTHINK GREEN LIMITEDHGY2026-09-20
09420060201055haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201062haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201079haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201086haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201093haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201680haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201697haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201703haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201710haakaaTHINK GREEN LIMITEDHGY2026-09-18
06925546001882ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-28
06925546001981ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-28
06925546020814ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-28
06925546002087Figaroo™ GlideCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-23
08809108019097SpectraUZINMEDICARE CO.,LTDHGY2025-10-15
00810104130936 Wave Single Manual Pump KitWILLOW INNOVATIONS, INC.HGY2025-07-23