MediBio

GUDID 06972040111067

Shenzhen AOJ Medical Technology Co., Ltd

Pulse oximeter

• Primary Device ID: 06972040111067
• NIH Device Record Key: b87f27fc-4901-45a5-9c69-77c151f1592c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediBio
• Version Model Number: AOJ-70E
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	06972040111067 [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: 2022-03-24
• Device Publish Date: 2022-03-16

Devices Manufactured by Shenzhen AOJ Medical Technology Co., Ltd

• 16972040110678 - DrBash: 2024-09-06
• 16972040110715 - DrBash: 2024-09-06
• 06972040112514 - Medisana: 2024-05-31
• 06972040112538 - Medisana: 2024-05-31
• 06972040112545 - Medisana: 2024-05-31
• 06972040112552 - Medisana: 2024-05-31
• 06972040112569 - Medisana: 2024-05-31
• 06972040112576 - Medisana: 2024-05-31