RXi® Cable

GUDID 30841716101503

RXi Ao box transducer cable p/n 301745-001

ACIST MEDICAL SYSTEMS, INC.

Cardiac catheterization laboratory computer

• Primary Device ID: 30841716101503
• NIH Device Record Key: 34c47c11-d32d-4660-aace-44d788ecf666
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RXi® Cable
• Version Model Number: 018363
• 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	30841716101503 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

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• 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
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• 30841716100414: RXi Pa Cable, p/n 301412-002
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• 30841716100391: RXi Pa Cable, p/n 301410-002
• 30841716100377: RXi Cable, p/n 301613-001
• 30841716100360: RXi Pa Splitter, p/n 301616-001