AccessGUDID - DEVICE: TELEVISIT SOLUTIONS (00628250477016)

GUDID

Device Identifier (DI) Information

Brand Name: TELEVISIT SOLUTIONS
Version or Model: TVS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Primonics (2006) Inc

Primary DI Number: 00628250477016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 248262656 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17148	Pulse oximeter, line-powered	A mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062338	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c936d71e-3ead-4526-83e4-5e359f6720e0
Public Version Date: January 18, 2019
Public Version Number: 1
DI Record Publish Date: December 18, 2018