FreeStyle Libre - FS Libre Sensor Kit - ABBOTT DIABETES CARE INC

Duns Number:966390890

Device Description: FS Libre Sensor Kit

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More Product Details

Catalog Number

71942

Brand Name

FreeStyle Libre

Version/Model Number

71942

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P160030,P160030

Product Code Details

Product Code

PZE

Product Code Name

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated

Device Record Status

Public Device Record Key

dd08639e-2008-44e0-8b5b-b8f54658633e

Public Version Date

October 28, 2022

Public Version Number

5

DI Record Publish Date

June 01, 2018

Additional Identifiers

Package DI Number

30357599000852

Quantity per Package

24

Contains DI Package

00357599000851

Package Discontinue Date

-

Package Status

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