Velcro cuff 1 tube, adults, 107.001

GUDID 04045396106802

Riester cuffs are used to generate pressure when measuring blood pressure.

Rudolf Riester GmbH

Blood pressure cuff, reusable

• Primary Device ID: 04045396106802
• NIH Device Record Key: 61add56f-e37a-4a04-83a9-16ee45c89c46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velcro cuff 1 tube, adults,
• Version Model Number: 107.001
• Catalog Number: 107.001
• 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	04045396106802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942777

FDA Product Code

• DXQ: Blood Pressure Cuff

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

On-Brand Devices [Velcro cuff 1 tube, adults,]

• 04045396215511: Riester cuffs are used to generate pressure when measuring blood pressure.
• 04045396106802: Riester cuffs are used to generate pressure when measuring blood pressure.