RVS-100 1960-RRXXU

GUDID 04045396216327

Vital Sign Monitoring

Rudolf Riester GmbH

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 04045396216327
• NIH Device Record Key: c5f6013d-1db7-4c76-a4bf-f0c6ba016218
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RVS-100
• Version Model Number: 1960-RRXXU
• Catalog Number: 1960-RRXXU
• 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: true
• 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	04045396216327 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-05-10

On-Brand Devices [RVS-100]

• 04045396217348: Vital Signs Monitoring
• 04045396216327: Vital Sign Monitoring
• 04045396215863: 1960-RNBPU
• 04045396214682: Vital Signs Moitoring
• 04045396212718: Vital Signs Monitoring
• 04045396000216: Vital Signs Monitoring