LEAK TEST AIR TUBE

GUDID 04953170299360

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope leak tester, electrical
Primary Device ID04953170299360
NIH Device Record Keyac6f12c9-422b-4792-98c3-6d2d3ac042c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEAK TEST AIR TUBE
Version Model NumberMAJ-1905
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)401-1086
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Device Identifiers

Device Issuing AgencyDevice ID
GS104953170299360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEBACCESSORIES, CLEANING, FOR ENDOSCOPE

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 Date2016-09-21

On-Brand Devices [LEAK TEST AIR TUBE]

04953170299360MAJ-1905
04953170069451MAJ-821
04953170404160MAJ-2127
04953170438264MAJ-821

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