Catalog Number

-

Brand Name

Lumipulse G Wash Solution

Version/Model Number

4008248

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

K142895

Product Code

JJE

Product Code Name

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Public Device Record Key

6dc5d1e2-7558-4429-acd6-5c3a295b230a

Public Version Date

July 15, 2020

Public Version Number

5

DI Record Publish Date

October 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-