Catalog Number

940

Brand Name

Pip

Version/Model Number

940

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 13, 2026

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K113208,K113208,K113208

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

ffde8c92-faae-4505-8d5c-9ffe10fc8420

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Package DI Number

10732671109405

Quantity per Package

1

Contains DI Package

00732671009401

Package Discontinue Date

May 13, 2026

Package Status

In Commercial Distribution

Package Type

Chipboard Carton