Catalog Number

-

Brand Name

RAMP® 200 TM Test Module

Version/Model Number

C3100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K071591

Product Code

KHO

Product Code Name

Fluorometer, For Clinical Use

Public Device Record Key

a317146e-8aef-4e88-920c-5b41a0e1b3ed

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-