ARGUS® PB-1000 3.920978

GUDID 07613365000092

The ARGUS® PB-1000 parameter box is acquiring and monitoring patients vital parameters such as ECG, invasive blood pressure (IBP), temperature, non-invasive blood pressure (NIPB), CO2, SpO2 and Cardiac Output. All vital parameters and evaluations are registered and calculated in the ARGUS® PB-1000. This data is then transmitted to the visualization unit via a serial interface.

Schiller AG

Patient monitoring system module, multifunction

• Primary Device ID: 07613365000092
• NIH Device Record Key: 543774c5-0d2e-4796-9bf5-318df376abc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARGUS® PB-1000
• Version Model Number: 3.920978
• Catalog Number: 3.920978
• Company DUNS: 480868538
• Company Name: Schiller AG
• 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

Customer Support Contacts

• Phone: +41417664242
• Email: info@schiller.ch

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613365000092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012226

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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: 2020-02-10
• Device Publish Date: 2016-09-18

On-Brand Devices [ARGUS® PB-1000]

• 07613365000092: The ARGUS® PB-1000 parameter box is acquiring and monitoring patients vital parameters such as
• 07613365000085: The ARGUS® PB-1000 parameter box is acquiring and monitoring patients vital parameters such as