SphygmoCor

GUDID 19351315000031

Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus various components (SphygmoCor XCEL software DVD, product

ATCOR MEDICAL PTY LTD

Patient monitoring system module, multifunction

• Primary Device ID: 19351315000031
• NIH Device Record Key: 1b7eaf99-cf02-426d-8833-6c9a77536c48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SphygmoCor
• Version Model Number: XCEL
• 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	19351315000031 [Primary]
GS1	19351315000048 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122129

FDA Product Code

• DSK: Computer, Blood-Pressure

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