FDA.reportPublic FDA data

Unimom

Primary DI
08809224872279
Brand
Unimom
Company
UNIMOM CO.
Model
Opera eco
Device description
The Opera eco is multiple-user, powered breast pumps intended to help a mother, especially those who have an excess of milk or have difficulty breast-feeding, extract residual milk from her breast
Published
2019-10-04
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190810000OPERA, OPERA ecoUnimom.Co2019-08-30HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809224872279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809224872279088092248722798809224872279

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
689057658
Device count
1
Kit
true
Serial number
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
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
08809224872224UnimomBreast Shield Kit SE (Extra Large)2018-12-13
08809224872019UnimomMinuet LCD2018-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07640108055965Breast shell sterile DeTach 15 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
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
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