FreeStyle - FreeStyle Lancing Device II - ABBOTT DIABETES CARE LTD

Duns Number:763477098

Device Description: FreeStyle Lancing Device II

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More Product Details

Catalog Number

71552

Brand Name

FreeStyle

Version/Model Number

71552

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMK

Product Code Name

Lancet, blood

Device Record Status

Public Device Record Key

716a8be0-a55b-4141-ab48-006740945007

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 15, 2021

Additional Identifiers

Package DI Number

35021791715528

Quantity per Package

100

Contains DI Package

05021791715527

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ABBOTT DIABETES CARE LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 2