Catalog Number

TZ202055

Brand Name

Sensium Vitals

Version/Model Number

US Patch

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110809,K110809,K110809

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

80cb57b7-362d-4d8e-9a59-7727cae8f35b

Public Version Date

January 31, 2019

Public Version Number

1

DI Record Publish Date

December 31, 2018

Package DI Number

05060403780065

Quantity per Package

10

Contains DI Package

05060403780058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper