FDA.reportPublic FDA data

Evolve Breast Pump

Primary DI
00865278000462
Brand
Evolve Breast Pump
Company
HYGEIA II MEDICAL GROUP INC
Model
10-0150
Device description
A hospital grade double electric breast pump, powered by AC or battery power, used to extract milk from a mother’s breast. The milk will be collected and used to feed infants. The device permits a user to vary the suction strength, and with the use of accessory parts to collect and funnel the breast milk into storage containers. The device utilizes protective measures to prevent the build-up of excessive negative pressure.
Published
2018-07-05
Public version status
Update
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
K081932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081932000ENDEARE BREAST PUMPHygeia Medical, Inc.2009-01-22HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865278000462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865278000462008652780004628652780004620865278000462

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
033147467
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013900879Nova LuxeNova Luxe10-03612026-04-01
00850013900930EspritEsprit10-03922026-04-01
00850013900336Express Powered breast pump10-03182024-07-10
00850013900305FIT Pro10-03092023-08-01
00860001425239Evolve10-01622019-06-21
00860001425246Evolve Breast Pump10-01632019-06-21
00860001425253Evolve Breast Pump10-01642019-06-21
00860001425260Evolve10-01652019-06-21
00860001425277Evolve Breast Pump10-01662019-06-21
00860001425284Evolve Breast Pump10-01672019-06-21
00865278000479Evolve Breast Pump10-01512018-07-05
00865278000486Evolve Breast Pump, PAS10-01522018-07-05
00896570002007EnDeare Breaast Pump10.00012016-08-23
00896570002014EnJoye Cordless Breast Pump10.00262016-08-23
00896570002021EnJoye Freedom Breast Pump10.00292016-08-23
00896570002243EnDeare Breast Pump10.00252016-08-23
00896570002250EnJoye Breast Pump10.00042016-08-23
00896570002274EnJoye Breast Pump 10.01852016-08-23
00896570002298EnJoye Freedom Breast Pump10.00302016-08-23
00896570002601EnJoye Cordless Breast Pump10.00442016-08-23

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