FreeStyle Libre 14 day - FreeStyle Libre 14 day Reader Kit US - ABBOTT DIABETES CARE INC

Duns Number:966390890

Device Description: FreeStyle Libre 14 day Reader Kit US

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More Product Details

Catalog Number

71938

Brand Name

FreeStyle Libre 14 day

Version/Model Number

71938

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"

-

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

362f7c3e-a17f-4f10-959c-49bcb5e6ad4d

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 14, 2019

Additional Identifiers

Package DI Number

30357599002009

Quantity per Package

4

Contains DI Package

00357599002008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"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