EnJoye Metal Luer lock

GUDID 00865278000417

Breast Pump EnJoye with Metal Luer Lock

HYGEIA II MEDICAL GROUP INC

Breast pump, electric
Primary Device ID00865278000417
NIH Device Record Keyc37b2b72-7e4f-420b-8dd5-863ff244cc9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnJoye Metal Luer lock
Version Model Number10-0055s3
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
GS100865278000417 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-07-17

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