Evolve Breast Pump, PAS

GUDID 00865278000486

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 ID00865278000486
NIH Device Record Keyef8ee784-2440-4ae6-a2ae-84c0f92bf786
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvolve Breast Pump, PAS
Version Model Number10-0152
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
GS100865278000486 [Primary]

FDA Product Code

HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-06
Device Publish Date2018-07-05

Devices Manufactured by HYGEIA II MEDICAL GROUP INC

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00865278000462 - Evolve Breast Pump2020-01-06 A hospital grade double electric breast pump, powered by AC or battery power, used to extract milk from a mother’s breast. The
00860001425239 - Evolve2019-07-01 Evolve Cordless Breast Pump, only pump
00860001425246 - Evolve Breast Pump2019-07-01 Evolve Cordless Breast pump, and Power supply
00860001425253 - Evolve Breast Pump2019-07-01 Evolve Cordless Breast pump, PAS, Power supply
00860001425260 - Evolve2019-07-01 Evolve Breast Pump, pump only
00860001425277 - Evolve Breast Pump2019-07-01 Evolve Breast Pump, pump & Power Supply

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