Catalog Number

2879-04-15

Brand Name

CTM-300

Version/Model Number

2879-04-15

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2016

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K083854

Product Code

DRT

Product Code Name

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Public Device Record Key

3f3076a9-3d9c-4c9e-a11e-ffe82300ff87

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-