Catalog Number

-

Brand Name

LUMISCOPE

Version/Model Number

1103

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K093359,K093359,K093359

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

b4d46525-056f-46ff-9760-f9f30af41cfb

Public Version Date

July 25, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

M36811033

Quantity per Package

4

Contains DI Package

M36811032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-