ENDOSCOPIC CO2 REGULATION UNIT

GUDID 04953170239113

"UCR ENDOSCOPIC CO2 REGULATION UNIT"

OLYMPUS MEDICAL SYSTEMS CORP.

Gastrointestinal endoscopic insufflator
Primary Device ID04953170239113
NIH Device Record Keyc0387d84-1555-4ad7-a60c-02c9accb425b
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOSCOPIC CO2 REGULATION UNIT
Version Model NumberOLYMPUS UCR
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 Batchfalse
Serial Numbertrue
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
GS104953170239113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCXINSUFFLATOR, AUTOMATIC CARBON-DIOXIDE 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 [ENDOSCOPIC CO2 REGULATION UNIT]

04953170239748OLYMPUS UCR
04953170239113"UCR ENDOSCOPIC CO2 REGULATION UNIT"

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