Vitals360

GUDID 10860007323406

Vitals360 Multi-Vitals Mobile Monitor VC-001

Vocare, Inc.

Pulse oximeter

• Primary Device ID: 10860007323406
• NIH Device Record Key: 59d04374-ce72-4984-8c77-835c0d9b8b3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitals360
• Version Model Number: VC-001
• Company DUNS: 833097525
• Company Name: Vocare, Inc.
• 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: true
• 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	00860007323409 [Primary]
GS1	10860007323406 [Package]; Contains: 00860007323409; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20860007323403 [Package]; Package: Case [12 Units]; In Commercial Distribution
GS1	30860007323400 [Package]; Contains: 20860007323403; Package: Pallet [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210086

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-18
• Device Publish Date: 2024-09-10