OptoMonitor 3 F201312

GUDID 07540184013128

Opsens Inc

Cardiac catheterization laboratory computer
Primary Device ID07540184013128
NIH Device Record Keyc7c87aa6-9e82-49a4-9e78-5f0a1e6402d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptoMonitor 3
Version Model NumberAO cable - Mckesson/Merge
Catalog NumberF201312
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 Batchfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107540184013128 [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 Date2024-12-13
Device Publish Date2024-12-05

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
07540184320127OpM3-DU Power Supply Cable
07540184320110OpM3-OU Power Supply Cable
07540184320103OpM3 OU-DU LAN Cable
07540184320097OpM3 OU-DU RS-232 comm cable
07540184040032Reference probe 18500nm
07540184040025Reference probe 14800nm
07540184040018Reference probe 16500nm
07540184013197AO cable - METEK David
07540184013180AO cable - Siemens Sensis 7pins
07540184013173AO cable - Fysicon QMAPP
07540184013166AO cable - Schwarzer Cardis 5000
07540184013159AO cable - Claris WorkMate
07540184013142AO cable - Ortivus Coronet
07540184013135AO cable - Siemens Recor
07540184013128AO cable - Mckesson/Merge
07540184013111AO cable - QynetiQ
07540184013104AO cable - BARD Clearsign
07540184013098AO cable - Mennen Model 267
07540184013074AO cable - Fukuda Denshi FCL-1000
07540184013067AO cable - Nihon Koden
07540184013050AO cable - GE CLAB II Plus 2.9m
07540184013043AO cable - Philips Xper Flex Cardio 2.9m
07540184013036AO transducer cable - Siemens Sensis
07540184013029AO cable - GE TRAM 2.9m
07540184013012AO cable - Philips/WITT 2.9m
07540184012206Pressure output cable - METEK David
07540184012190Pressure output cable - Siemens Sensis
07540184012183Pressure output cable - Fysicon QMAPP
07540184012176Pressure output cable - Philips XperFCII
07540184012169Pressure output cable - Schwarzer Cardis
07540184012152Pressure output cable - Claris WorkMate
07540184012145Pressure output cable - Ortivus CoroNet
07540184012077Pressure output cable - Fukuda Denshi FC
07540184012060Pressure output cable - Nihon Koden
07540184011186AUX interface cable - Siemens Vibe AO2
07540184011179AUX interface cable - Fysicon QMAPP
07540184011162AUX interface cable - Schwarzer Cardis
07540184011155AUX interface cable - Siemens Vibe
07540184011148AUX interface cable - GE X5
07540184011131AUX interface cable - GE TRAM D15 S4 WB
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