Catalog Number

L-96102

Brand Name

Xhibit

Version/Model Number

96102

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 08, 2016

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122146

Product Code

DSI

Product Code Name

DETECTOR AND ALARM, ARRHYTHMIA

Public Device Record Key

afe42340-9e09-474d-b2b8-1cf9a851ca24

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

October 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-