Catalog Number

-

Brand Name

Mini Telemetry System

Version/Model Number

2051440-002

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

K110556

Product Code

HGM

Product Code Name

SYSTEM, MONITORING, PERINATAL

Public Device Record Key

ca6fe679-ee1d-4f22-8b68-910415df91d1

Public Version Date

December 10, 2019

Public Version Number

4

DI Record Publish Date

June 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-