Catalog Number

-

Brand Name

LUMISCOPE

Version/Model Number

100-040BK

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

K082542,K082542

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

f15b5788-e6b3-4258-8393-7f6e36a9cc3f

Public Version Date

July 25, 2019

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

M368100040BK2

Quantity per Package

12

Contains DI Package

M368100040BK1

Package Discontinue Date

-

Package Status

-

Package Type

-