CER-1 Optima

GUDID 00677964052484

MEDIVATORS INC.

Endoscope washer/disinfector
Primary Device ID00677964052484
NIH Device Record Key3a278a55-ce29-430d-8adc-959f991b36bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCER-1 Optima
Version Model NumberCER-1 Optima
Company DUNS068199363
Company NameMEDIVATORS 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100677964052484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVEWasher, Cleaner, Automated, Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-20

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