LPOW

GUDID 00850063675130

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

• Primary Device ID: 00850063675130
• NIH Device Record Key: 489d107a-6f0d-4ff9-b6c9-26ffe784bf7b
• Commercial Distribution Discontinuation: 2024-05-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LPOW
• Version Model Number: GF-MT509
• 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: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850063675130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102718

FDA Product Code

• OZK: Thermometer, Exhaled Breath

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: 2024-06-05
• Device Publish Date: 2024-05-28

Devices Manufactured by Hangzhou Universal Electronic Co.,Ltd.

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