BodiMetrics

GUDID 06934440100713

Shenzhen Viatom Technology Co., Ltd.

Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use

• Primary Device ID: 06934440100713
• NIH Device Record Key: e327f993-e9f5-4d88-bba2-d3e1db7c3037
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodiMetrics
• Version Model Number: VitalsRX Health Monitor
• 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: false
• 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	06934440100713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150869

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-09-09
• Device Publish Date: 2019-07-23

Devices Manufactured by Shenzhen Viatom Technology Co., Ltd.

• 16934440100024 - Viatom: 2023-12-20
• 06934440101994 - Viatom: 2023-07-27
• 06934440101888 - Sleepimage: 2023-06-14
• 06934440100676 - Viatom: 2021-08-09
• 06934440100850 - Wellue: 2021-08-09
• 06934440101017 - Wellue/Viatom: 2021-08-09
• 06934440100010 - Viatom: 2020-09-09
• 06934440100713 - BodiMetrics: 2020-09-09
• 06934440100713 - BodiMetrics: 2020-09-09