OptoMonitor F201111

GUDID 07540184011117

Opsens Inc

Electrical-only medical device connection cable, reusable
Primary Device ID07540184011117
NIH Device Record Keyde983eed-be24-454a-b798-4286d920f0b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptoMonitor
Version Model NumberPa input cable - GE TRAM 450SL
Catalog NumberF201111
Company DUNS253717946
Company NameOpsens Inc
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com
Phone418-781-0333
Emailinfo-medical@opsens.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107540184011117 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [OptoMonitor]

07540184020300Handle Unit
07540184020201Display Unit
07540184020102Optical Unit
07540184020010OpM OU‐DU Communication cable
07540184012138Pd Interface cable to Siemens Recor
07540184012121Pd Interface cable to McK/Merge
07540184012114Pd Interface cable to Qynetiq
07540184012107Pd Interface cable ‐ Bard Clearsign
07540184012091Pd interface Mennen Model 267
07540184012053Pd Interface cable to GE CLAB II Plus
07540184012046Pd Interface cable to Philips XPER FC
07540184012039Pd interface cable ‐ Siemens Axiom Sensis
07540184012022Pd Interface cable to GE TRAM
07540184012015Pd Interface Cable ‐ Philips/Witt
07540184011124Pa input cable - Siemens Axiom Sensis output 1
07540184011117Pa input cable - GE TRAM 450SL
07540184011100Pa input cable ‐ PDM
07540184011094Pa input cable ‐ Jack 3.5mm
07540184011087Pa input cable Mennen CFE
07540184011070Pa input cable Siemens Sensis iSIB
07540184011063Pa input cable Mennen model 267
07540184011056Pa input cable D15 GE TRAM
07540184011049Pa input cable GE TRAM
07540184011032Pa input cable ‐ Jack 1/4"
07540184011025Pa input cable ‐ Siemens Axiom Sensis
07540184011018Pa input cable ‐ BNC
07540184010042AC Power cord
07540184010035Power supply
07540184023226OpM3-DU Wireless dongle

Trademark Results [OptoMonitor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTOMONITOR
OPTOMONITOR
86384225 5069180 Live/Registered
OPSENS INC.
2014-09-03
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