fridababy

GUDID 00810028770614

Shenzhen AOJ Medical Technology Co., Ltd

Infrared patient thermometer, skin

• Primary Device ID: 00810028770614
• NIH Device Record Key: dc35193c-c5b5-430d-8881-9fb78bd38fa2
• Commercial Distribution Discontinuation: 2021-02-28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: fridababy
• Version Model Number: FB068
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810028770614 [Primary]
GS1	20810028770618 [Package]; Package: [12 Units]; Discontinued: 2020-10-14; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182133

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: 2021-01-20
• Device Publish Date: 2021-01-12

On-Brand Devices [fridababy]

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