TELEVISIT SOLUTIONS

GUDID 00628250477016

The Televisit software is intended for the purposes of collecting physiological data such as: Non-Invasive Blood Pressure; Pulse Oximetry, Temperature and Breath Sounds (Auscultation), Spirometer, Glucometer and E.C.G. The intended use of the Televisit software is in hospital/clinical environments with established specialized care providing access to each patient in their home and/or local community health center. Televisit software is a non-invasive medical device, which does not flag any abnormal results from the medical device inputs. The Televisit software does not monitor, assess or diagnose a disease, a disorder, or an abnormal physical state. The intended use for the software is data acquisition and collection only, with no treatment function or danger to the end user. The data obtained from Televisit software can be used only as an aid in the diagnosis and treatment of the patient.

Primonics (2006) Inc

Pulse oximeter, line-powered

• Primary Device ID: 00628250477016
• NIH Device Record Key: c936d71e-3ead-4526-83e4-5e359f6720e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TELEVISIT SOLUTIONS
• Version Model Number: TVS
• Company DUNS: 248262656
• Company Name: Primonics (2006) Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: 514-694-4866
• Email: jamil.qadri@televisitsolutions.com
• Phone: 514-694-4866
• Email: jamil.qadri@televisitsolutions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628250477016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062338

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: 2019-01-18
• Device Publish Date: 2018-12-18