Viatom

GUDID 16934440100024

Shenzhen Viatom Technology Co., Ltd.

Pulse oximeter

• Primary Device ID: 16934440100024
• NIH Device Record Key: 91691533-41a8-4b9e-946d-5678f2d92d19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viatom
• Version Model Number: PO6 Oxyfit Pulse Oximeter
• 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	06934440102311 [Primary]
GS1	16934440100024 [Package]; Contains: 06934440102311; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203812

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: 2023-12-20
• Device Publish Date: 2023-12-12

On-Brand Devices [Viatom]

• 06934440100010: Checkme Pro Health Monitor
• 06934440100676: Oxiband (Checkme) O2 Pulse Oximeter
• 06934440101994: PO6 Oxyfit Pulse Oximeter
• 16934440100024: PO6 Oxyfit Pulse Oximeter
• 06934440102601: Checkme O2 Pulse Oximeter