Catalog Number

08243930190

Brand Name

CalSet PTH STAT

Version/Model Number

08243930190

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JIT

Product Code Name

Calibrator, secondary

Public Device Record Key

3ca9e727-72a9-4e57-9f6f-5767aadb581c

Public Version Date

December 23, 2019

Public Version Number

2

DI Record Publish Date

March 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-