OptoMonitor 3 F232012

GUDID 07540184020126

Opsens Inc

Cardiac catheterization laboratory computer
Primary Device ID07540184020126
NIH Device Record Key1f899b77-03e9-46fa-a6fb-a3125499faf2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptoMonitor 3
Version Model NumberOpM3-DU Power Supply Cable
Catalog NumberF232012
Company DUNS253717946
Company NameOpsens Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107540184020126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXOTransducer, Pressure, Catheter Tip

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-28
Device Publish Date2020-07-20

On-Brand Devices [OptoMonitor 3]

07540184132010OpM3 OU-DU LAN Cable
07540184023301OpM3 Handle Unit
07540184023219OpM3 Display Unit 15"
07540184023202OpM3 Display Unit 10"
07540184023103OpM3 Optical Unit
07540184020126OpM3-DU Power Supply Cable
07540184020119OpM3-OU Power Supply Cable
07540184020096OpM3 OU-DU RS-232 comm cable

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.