Catalog Number

-

Brand Name

ASSURE® PRISM MULTI BLOOD GLUCOSE TEST STRIPS

Version/Model Number

530050 / 530100

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151164,K151164,K151164,K151164,K151164,K151164,K151164

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

0361c73c-bbe2-4686-99fe-f28bff84a65e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 17, 2017

Package DI Number

20015482530505

Quantity per Package

45

Contains DI Package

10015482530508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Shipper