Catalog Number

700-0007-38

Brand Name

Trulink

Version/Model Number

AMC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 29, 2019

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

K103142

Product Code

DSI

Product Code Name

DETECTOR AND ALARM, ARRHYTHMIA

Public Device Record Key

afc0428d-4b42-40bf-b6ad-b96dc1f02325

Public Version Date

July 01, 2019

Public Version Number

5

DI Record Publish Date

October 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-