OptoMonitor 3 F2330

GUDID 07540184023301

Opsens Inc

Cardiac catheterization laboratory computer
Primary Device ID07540184023301
NIH Device Record Key8a3a0d4b-a764-4466-95f8-2e994f61ae6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptoMonitor 3
Version Model NumberOpM3 Handle Unit
Catalog NumberF2330
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 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

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
GS107540184023301 [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

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