Viatom

GUDID 16934440100024

Shenzhen Viatom Technology Co., Ltd.

Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter 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