SphygmoCor

GUDID 19351315000017

Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer

ATCOR MEDICAL PTY LTD

Patient monitoring system module, multifunction

• Primary Device ID: 19351315000017
• NIH Device Record Key: d490db9a-5c83-4f48-9527-49012db72b13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SphygmoCor
• Version Model Number: CVMS
• Company DUNS: 751626706
• Company Name: ATCOR MEDICAL PTY LTD
• Device Count: 1
• DM Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	19351315000017 [Primary]
GS1	19351315000024 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070795

FDA Product Code

• DRT: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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: 2016-09-22

On-Brand Devices [SphygmoCor]

• 19351315000031: Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus vari
• 19351315000017: Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus vari