OptoMonitor F201111

GUDID 07540184011117

Opsens Inc

Electrical-only medical device connection cable, reusable

• Primary Device ID: 07540184011117
• NIH Device Record Key: de983eed-be24-454a-b798-4286d920f0b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptoMonitor
• Version Model Number: Pa input cable - GE TRAM 450SL
• Catalog Number: F201111
• Company DUNS: 253717946
• Company Name: Opsens Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: 418-781-0333
• Email: info-medical@opsens.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540184011117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142598

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [OptoMonitor]

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