FDA.reportPublic FDA data

Evolve

Primary DI
00860001425239
Brand
Evolve
Company
HYGEIA II MEDICAL GROUP INC
Model
10-0162
Device description
Evolve Cordless Breast Pump, only pump
Published
2019-06-21
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
00860001425239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001425239008600014252398600014252390860001425239

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
00860001425246Evolve Breast Pump10-01632019-06-21
00860001425253Evolve Breast Pump10-01642019-06-21
00860001425260Evolve10-01652019-06-21
00860001425277Evolve Breast Pump10-01662019-06-21
00865278000462Evolve Breast Pump10-01502018-07-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)Ardo medical AGHGX2026-07-31
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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06925546003381ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
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06937266900109FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
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00810104131032Willow Sync Duckbill ValvesWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131049Willow Sync DiaphragmsWILLOW INNOVATIONS, INC.HGX2026-07-16