Express Powered breast pump

GUDID 00850013900336

Express Powered Breast Pump

HYGEIA II MEDICAL GROUP INC

Breast pump, electric
Primary Device ID00850013900336
NIH Device Record Key5f15fdcd-e75f-46a8-830d-886458e2a0dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameExpress Powered breast pump
Version Model Number10-0318
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

Customer Support Contacts

Phone714-515-7571
Emailcustomer.service@hygeiahealth.com
Phone714-515-7571
Emailcustomer.service@hygeiahealth.com
Phone714-515-7571
Emailcustomer.service@hygeiahealth.com
Phone714-515-7571
Emailcustomer.service@hygeiahealth.com
Phone714-515-7571
Emailcustomer.service@hygeiahealth.com
Phone714-515-7571
Emailcustomer.service@hygeiahealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850013900336 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-18
Device Publish Date2024-07-10

Devices Manufactured by HYGEIA II MEDICAL GROUP INC

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00860001425239 - Evolve2019-07-01 Evolve Cordless Breast Pump, only pump
00860001425246 - Evolve Breast Pump2019-07-01 Evolve Cordless Breast pump, and Power supply
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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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