LEAK TEST AIR TUBE N6178501

GUDID 04953170438264

OLYMPUS MEDICAL SYSTEMS CORP.

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Primary Device ID04953170438264
NIH Device Record Key0999498c-a9a0-478c-b47d-7f760b4fc91c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEAK TEST AIR TUBE
Version Model NumberMAJ-821
Catalog NumberN6178501
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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Phone+1(800)401-1086
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Device Identifiers

Device Issuing AgencyDevice ID
GS104953170438264 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-01
Device Publish Date2023-04-22

On-Brand Devices [LEAK TEST AIR TUBE]

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

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