DrBash

GUDID 16972040110678

Shenzhen AOJ Medical Technology Co., Ltd

Infrared patient thermometer, ear/skin

• Primary Device ID: 16972040110678
• NIH Device Record Key: afe7aeed-482c-4248-8eb5-6754e2186337
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrBash
• Version Model Number: AOJ-20B
• Company DUNS: 554409093
• Company Name: Shenzhen AOJ Medical Technology Co., Ltd
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• 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	06972040113498 [Primary]
GS1	16972040110678 [Package]; Contains: 06972040113498; Package: Color box [1 Units]; Discontinued: 2029-08-18; In Commercial Distribution
GS1	26972040110606 [Package]; Contains: 06972040113498; Package: outer box [50 Units]; Discontinued: 2029-08-18; In Commercial Distribution
GS1	36972040110122 [Package]; Contains: 06972040113498; Package: outer box [100 Units]; Discontinued: 2029-08-18; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221039

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2024-09-06
• Device Publish Date: 2024-08-29

On-Brand Devices [DrBash]

• 16972040110715: AOJ-30F
• 16972040110678: AOJ-20B