RXi® Cable

GUDID 30841716102067

RXi, GE PDM Adapter, p/n 301666-001

ACIST MEDICAL SYSTEMS, INC.

Cardiac catheterization laboratory computer

• Primary Device ID: 30841716102067
• NIH Device Record Key: 0824119c-ab95-4dbe-9923-f801cdb79fd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RXi® Cable
• Version Model Number: 018062
• Company DUNS: 926684994
• Company Name: ACIST MEDICAL SYSTEMS, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30841716102067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132474

FDA Product Code

• OBI: Catheter, Pressure Monitoring, Cardiac

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: 2018-10-29
• Device Publish Date: 2018-09-26

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• 30841716102067: RXi, GE PDM Adapter, p/n 301666-001
• 30841716102012: RXi Medex cable, p/n 301831-001
• 30841716101725: RXi Medex adapter cable, p/n 301832-001
• 30841716101718: RXi Medex cable, p/n 301863-002
• 30841716101701: RXi Medex adapter cable, p/n 301862-001
• 30841716101510: RXi Ao box transducer cable, p/n 301746-001
• 30841716101503: RXi Ao box transducer cable p/n 301745-001
• 30841716101497: RXi Ao box transducer cable p/n 301744-001
• 30841716101480: RXi Ao box transducer cable p/n 301743-001
• 30841716101473: RXi Ao box transducer cable, p/n 301742-001
• 30841716101466: RXi Ao box transducer cable, p/n 301741-001
• 30841716101459: RXi Ao box transducer cable, p/n 301740-001
• 30841716100575: RXi Pa Cable p/n 301716-001
• 30841716100568: RXi Pa Splitter, p/n 301614-001
• 30841716100551: RXi PDM Cable, p/n 301611-001
• 30841716100544: RXi Splitter, p/n 301600-001
• 30841716100537: RXi BNC Adapter, p/n 301599-001
• 30841716100520: RXi BNC to Mono Adapter, p/n 301598-001
• 30841716100513: RXi BNC to Mono Adapter, p/n 301597-001
• 30841716100506: RXi Pa Cable, p/n 301587-002
• 30841716100490: RXi Pd Adapter Cable, p/n 301561-001
• 30841716100483: RXi Pa Splitter, p/n 301505-002
• 30841716100476: RXi Pa Splitter, p/n 301504-001
• 30841716100469: RXi BNC Connector, p/n 301503-001
• 30841716100452: RXi BNC Connector, p/n 301502-001
• 30841716100445: RXi Pa Cable, p/n 301450-002
• 30841716100438: RXi Pa Cable, p/n 301450-001
• 30841716100421: RXi Pa Cable, p/n 301414-002
• 30841716100414: RXi Pa Cable, p/n 301412-002
• 30841716100407: RXi Pa Cable, p/n 301411-002
• 30841716100391: RXi Pa Cable, p/n 301410-002
• 30841716100377: RXi Cable, p/n 301613-001
• 30841716100360: RXi Pa Splitter, p/n 301616-001