Catalog Number

942-1

Brand Name

Pip

Version/Model Number

942-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 13, 2026

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113208

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

6a7fe573-b762-4771-99b0-e5484f518a87

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-