FreeStyle InsuLinx - FreeStyle InsuLinx Blood Glucose Monitoring System - ABBOTT DIABETES CARE INC

Duns Number:966390890

Device Description: FreeStyle InsuLinx Blood Glucose Monitoring System

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More Product Details

Catalog Number

71150

Brand Name

FreeStyle InsuLinx

Version/Model Number

71150

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 02, 2020

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152328,K152328

Product Code Details

Product Code

LFR

Product Code Name

Glucose dehydrogenase, glucose

Device Record Status

Public Device Record Key

c85a8f16-37e3-47bf-a4b5-41c1b466714b

Public Version Date

January 18, 2021

Public Version Number

4

DI Record Publish Date

August 26, 2016

Additional Identifiers

Package DI Number

30093815711507

Quantity per Package

4

Contains DI Package

00093815711506

Package Discontinue Date

May 02, 2020

Package Status

Not in Commercial Distribution

Package Type

Case

"ABBOTT DIABETES CARE INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 19
3 A medical device with high risk that requires premarket approval 2