OptoMonitor 3 F232011

GUDID 07540184020119

Opsens Inc

Cardiac catheterization laboratory computer

• Primary Device ID: 07540184020119
• NIH Device Record Key: 0b995237-5e42-4516-b84b-8d9f4e4601a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptoMonitor 3
• Version Model Number: OpM3-OU Power Supply Cable
• Catalog Number: F232011
• Company DUNS: 253717946
• Company Name: Opsens Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540184020119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193620

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-28
• Device Publish Date: 2020-07-20

On-Brand Devices [OptoMonitor 3]

• 07540184132010: OpM3 OU-DU LAN Cable
• 07540184023301: OpM3 Handle Unit
• 07540184023219: OpM3 Display Unit 15"
• 07540184023202: OpM3 Display Unit 10"
• 07540184023103: OpM3 Optical Unit
• 07540184020126: OpM3-DU Power Supply Cable
• 07540184020119: OpM3-OU Power Supply Cable
• 07540184020096: OpM3 OU-DU RS-232 comm cable
• 07540184320127: OpM3-DU Power Supply Cable
• 07540184320110: OpM3-OU Power Supply Cable
• 07540184320103: OpM3 OU-DU LAN Cable
• 07540184320097: OpM3 OU-DU RS-232 comm cable
• 07540184040032: Reference probe 18500nm
• 07540184040025: Reference probe 14800nm
• 07540184040018: Reference probe 16500nm
• 07540184013197: AO cable - METEK David
• 07540184013180: AO cable - Siemens Sensis 7pins
• 07540184013173: AO cable - Fysicon QMAPP
• 07540184013166: AO cable - Schwarzer Cardis 5000
• 07540184013159: AO cable - Claris WorkMate
• 07540184013142: AO cable - Ortivus Coronet
• 07540184013135: AO cable - Siemens Recor
• 07540184013128: AO cable - Mckesson/Merge
• 07540184013111: AO cable - QynetiQ
• 07540184013104: AO cable - BARD Clearsign
• 07540184013098: AO cable - Mennen Model 267
• 07540184013074: AO cable - Fukuda Denshi FCL-1000
• 07540184013067: AO cable - Nihon Koden
• 07540184013050: AO cable - GE CLAB II Plus 2.9m
• 07540184013043: AO cable - Philips Xper Flex Cardio 2.9m
• 07540184013036: AO transducer cable - Siemens Sensis
• 07540184013029: AO cable - GE TRAM 2.9m
• 07540184013012: AO cable - Philips/WITT 2.9m
• 07540184012206: Pressure output cable - METEK David
• 07540184012190: Pressure output cable - Siemens Sensis
• 07540184012183: Pressure output cable - Fysicon QMAPP
• 07540184012176: Pressure output cable - Philips XperFCII
• 07540184012169: Pressure output cable - Schwarzer Cardis
• 07540184012152: Pressure output cable - Claris WorkMate
• 07540184012145: Pressure output cable - Ortivus CoroNet
• 07540184012077: Pressure output cable - Fukuda Denshi FC
• 07540184012060: Pressure output cable - Nihon Koden
• 07540184011186: AUX interface cable - Siemens Vibe AO2
• 07540184011179: AUX interface cable - Fysicon QMAPP
• 07540184011162: AUX interface cable - Schwarzer Cardis
• 07540184011155: AUX interface cable - Siemens Vibe
• 07540184011148: AUX interface cable - GE X5
• 07540184011131: AUX interface cable - GE TRAM D15 S4 WB