Catalog Number

LCF

Brand Name

Spacelabs Healthcare

Version/Model Number

LCF

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 05, 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

-

Product Code

MWJ

Product Code Name

Electrocardiograph, ambulatory (without analysis)

Public Device Record Key

d1071a4a-4c88-408a-8e15-09dda61f5a0c

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

August 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-