None

GUDID 00860007291128

Hangzhou Universal Electronic Co.,Ltd.

Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer

• Primary Device ID: 00860007291128
• NIH Device Record Key: 644bdcb0-9a39-46f9-bccc-f80a3c06b3bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: None
• Version Model Number: 9500
• Company DUNS: 679945639
• Company Name: Hangzhou Universal Electronic 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: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007291128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102718

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: 2022-06-08
• Device Publish Date: 2022-05-31

Devices Manufactured by Hangzhou Universal Electronic Co.,Ltd.

• 00850063675130 - LPOW: 2024-06-05
• 00860007291128 - None: 2022-06-08
• 00860007291128 - None: 2022-06-08
• 00860007291111 - Familycare: 2021-10-28