Fluid Monitoring Unit

GUDID 04056702005689

W.O.M. World of Medicine GmbH

Hysteroscopic irrigation/insufflation system
Primary Device ID04056702005689
NIH Device Record Keyc8f7fade-cfab-45af-a66b-248a910eeb63
Commercial Distribution StatusIn Commercial Distribution
Brand NameFluid Monitoring Unit
Version Model NumberPS304
Company DUNS316305242
Company NameW.O.M. World of Medicine GmbH
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056702005689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIGInsufflator, Hysteroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-16

On-Brand Devices [Fluid Monitoring Unit]

04056702005689PS304
04056702012878PS304

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