AIR/WATER VALVE

GUDID 04953170209680

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic procedure air/water valve, reusable
Primary Device ID04953170209680
NIH Device Record Keyd59ecbb0-9e50-48e5-a137-6ffb5a1dcb02
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIR/WATER VALVE
Version Model NumberMAJ-1444
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count1
DM Exempttrue
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
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170209680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWBEndoscope, accessories, narrow band spectrum

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170209680]

Moist Heat or Steam Sterilization;Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2018-10-08
Device Publish Date2017-10-06

On-Brand Devices [AIR/WATER VALVE]

04953170209680MAJ-1444
04953170156113MAJ-1248, AIR/WATER VALVE FOR PEF-V
04953170438066MH-438

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