Evolve Breast Pump

GUDID 00865278000462

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.

HYGEIA II MEDICAL GROUP INC

Breast pump, electric
Primary Device ID00865278000462
NIH Device Record Keyb2b7f7d3-feeb-4018-a4e7-4c7f8322e104
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvolve Breast Pump
Version Model Number10-0150
Company DUNS033147467
Company NameHYGEIA II MEDICAL GROUP INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100865278000462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-06
Device Publish Date2018-07-05

On-Brand Devices [Evolve Breast Pump]

00865278000479A hospital grade double electric breast pump, powered by AC or battery power, used to extract mi
00865278000462A hospital grade double electric breast pump, powered by AC or battery power, used to extract mi
00860001425284Evolve Breast Pump, pump & Power Supply
00860001425277Evolve Breast Pump, pump & Power Supply
00860001425253Evolve Cordless Breast pump, PAS, Power supply
00860001425246Evolve Cordless Breast pump, and Power supply

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