Catalog Number

-

Brand Name

PENTRA C400 STD

Version/Model Number

1300018784

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K052007

Product Code

JJE

Product Code Name

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

Public Device Record Key

88ec71b8-38c0-4c9f-bbf2-aaf6d0d291c8

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-