LPOW

GUDID 00850063675130

Hangzhou Universal Electronic Co.,Ltd.

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.

• 00860011164913 - Boncare: 2025-04-04
• 00860011164920 - Boncare: 2025-04-04
• 06949395046009 - Boncare: 2025-03-31
• 00850063675130 - LPOW: 2024-06-05
• 00850063675130 - LPOW: 2024-06-05
• 00860007291128 - None: 2022-06-08
• 00860007291111 - Familycare: 2021-10-28