Catalog Number

-

Brand Name

LUMISCOPE

Version/Model Number

1143

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

32be2cf9-1389-43b0-8438-e4c1ae8a8c67

Public Version Date

September 20, 2022

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

M36811432

Quantity per Package

8

Contains DI Package

M36811431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-