Medisana

GUDID 06972040112538

Shenzhen AOJ Medical Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06972040112538
• NIH Device Record Key: f32c66dc-e35e-4b05-a050-0b037f805390
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medisana
• Version Model Number: BW 550
• Company DUNS: 554409093
• Company Name: Shenzhen AOJ Medical Technology Co., Ltd
• 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	06972040112538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213503

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-31
• Device Publish Date: 2024-05-23

On-Brand Devices [Medisana]

• 06972040112521: BU 550
• 06972040112583: TM 740 connect
• 06972040112576: TM 550
• 06972040112569: PM 550
• 06972040112552: PM 750 connect
• 06972040112545: BW 750 connect
• 06972040112538: BW 550
• 06972040112514: BU 750 connect