ALT-Pro LEAK TEST AIR TUBE

GUDID 04953170351778

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope leak tester, electrical
Primary Device ID04953170351778
NIH Device Record Key5e573f4a-9cb9-4183-9311-9efe16c63d8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameALT-Pro LEAK TEST AIR TUBE
Version Model NumberMAJ-2009
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
GS104953170351778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PCVEndoscopic leak tester

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

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