fridababy

GUDID 06972040111456

Shenzhen AOJ Medical Technology Co., Ltd

Intermittent electronic patient thermometer

• Primary Device ID: 06972040111456
• NIH Device Record Key: b48d02b7-9fd6-4ee6-9561-8a02531c0eda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: fridababy
• Version Model Number: AOJ-25B
• Company DUNS: 554409093
• Company Name: Shenzhen AOJ Medical Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	06972040111456 [Primary]
GS1	06972040111463 [Package]; Package: [12 Units]; Discontinued: 2023-04-17; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213485

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: 2022-11-08
• Device Publish Date: 2022-10-31

On-Brand Devices [fridababy]

• 00810028770614: FB068
• 06972040111432: AOJ-25B
• 06972040111456: AOJ-25B