Catalog Number

8103-01

Brand Name

VistaTablet

Version/Model Number

8103-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K193343,K193343

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

2a82f2e5-416d-4ef6-b00d-d9fba2cc8f2b

Public Version Date

November 10, 2020

Public Version Number

1

DI Record Publish Date

November 02, 2020

Package DI Number

00850490007405

Quantity per Package

1

Contains DI Package

00850490007399

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-