Pip - Blood Glucose Test Strips - AMITY HOLDINGS, LLC

Duns Number:016069284

Device Description: Blood Glucose Test Strips

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More Product Details

Catalog Number

941

Brand Name

Pip

Version/Model Number

941

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

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

K113208,K113208,K113208,K113208

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

213ad6d0-f9ff-4cd3-929b-ffb898491f2c

Public Version Date

April 11, 2022

Public Version Number

3

DI Record Publish Date

June 21, 2021

Additional Identifiers

Package DI Number

10732671109412

Quantity per Package

50

Contains DI Package

00732671009418

Package Discontinue Date

May 13, 2026

Package Status

In Commercial Distribution

Package Type

Plastic Vial

"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