Catalog Number

-

Brand Name

Telemetry Transmitter

Version/Model Number

iT20

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

K161056,K161056

Product Code

BZQ

Product Code Name

Monitor, Breathing Frequency

Public Device Record Key

86ff7801-64ce-4133-8e40-d6926a072a2e

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

February 22, 2017

Package DI Number

06944413802278

Quantity per Package

4

Contains DI Package

06944413802261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-