RVS-100,NIBP(Riester)+SpO2(Riester) + Pred. Temp 1960-RRBXG

GUDID 04045396214699

The RVS-100 vital signs monitor is intended to be used for monitoring, displaying, reviewing, storing and sending alarms regarding multiple physiological patient parameters, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (Temp).

Rudolf Riester GmbH

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• Primary Device ID: 04045396214699
• NIH Device Record Key: cc76b9e1-cf89-4b26-b9b3-1bda1ab0c5fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RVS-100,NIBP(Riester)+SpO2(Riester) + Pred. Temp
• Version Model Number: 1960-RRBXG
• Catalog Number: 1960-RRBXG
• Company DUNS: 537208717
• Company Name: Rudolf Riester GmbH
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04045396214699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170538

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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: 2021-02-05
• Device Publish Date: 2021-01-28

Devices Manufactured by Rudolf Riester GmbH

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