Pip - Control Solution - L2 (High) - AMITY HOLDINGS, LLC

Duns Number:016069284

Device Description: Control Solution - L2 (High)

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More Product Details

Catalog Number

942-2

Brand Name

Pip

Version/Model Number

942-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 13, 2026

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

46c23741-6e34-4f67-b1c7-b18d804b0c9a

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMITY HOLDINGS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 5