Medisana

GUDID 06972040112569

Shenzhen AOJ Medical Technology Co., Ltd

Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 06972040112569
• NIH Device Record Key: edbfbb73-445b-45db-98f1-5ec076aeacc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medisana
• Version Model Number: PM 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	06972040112569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202173

FDA Product Code

• DQA: Oximeter

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