Catalog Number

-

Brand Name

Pip Blood Glucose Test Strips

Version/Model Number

PS-004

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151658,K151658,K151658

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

ab587da5-8a88-4066-8521-00b3d54324d8

Public Version Date

September 21, 2020

Public Version Number

1

DI Record Publish Date

September 11, 2020

Package DI Number

08809301161777

Quantity per Package

2

Contains DI Package

08809301161760

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-