Flexmed

GUDID 00860000853125

RBD GROUP, LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00860000853125
• NIH Device Record Key: cbd8404a-c0a2-47ce-bec6-5d26b4fed8b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexmed
• Version Model Number: RBD002
• Company DUNS: 116729960
• Company Name: RBD GROUP, LLC
• 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: false
• 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	00860000853125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131558

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2019-03-15

On-Brand Devices [Flexmed]

• 00860000853125: RBD002
• 00860000853118: RBD001
• 00860000853101: RBD003