Wellue Checkme O2 Max

GUDID 06934440102793

Shenzhen Viatom Technology Co., Ltd.

Pulse oximeter

• Primary Device ID: 06934440102793
• NIH Device Record Key: dc36c3c6-66e0-401b-abd3-17ee9b91d354
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wellue Checkme O2 Max
• Version Model Number: Oxiband
• Company DUNS: 421357243
• Company Name: Shenzhen Viatom Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934440102793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191088

FDA Product Code

• DQA: Oximeter

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: 2024-12-06
• Device Publish Date: 2024-11-28

Devices Manufactured by Shenzhen Viatom Technology Co., Ltd.

• 06934440102069 - Checkme: 2025-01-01
• 06934440102212 - Wellue/Viatom: 2025-01-01
• 06934440102588 - LEPU MEDICAL: 2025-01-01
• 06934440102618 - BP2 Blood Pressure Monitor: 2025-01-01
• 06934440102748 - Checkme: 2025-01-01
• 06934440102755 - BP2A Blood Pressure Monitor: 2025-01-01
• 06934440102762 - LEPU MEDICAL: 2025-01-01
• 06934440102809 - Pulse Oximeter: 2024-12-31