FreeStyle - FreeStyle Control Solution - ABBOTT DIABETES CARE INC

Duns Number:966390890

Device Description: FreeStyle Control Solution

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More Product Details

Catalog Number

70432

Brand Name

FreeStyle

Version/Model Number

70432

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

JJX

Product Code Name

Single (specified) analyte controls (assayed and unassayed)

Device Record Status

Public Device Record Key

ba2f25f3-58bf-43ef-83a9-72f8513b0ef8

Public Version Date

May 14, 2018

Public Version Number

1

DI Record Publish Date

April 13, 2018

Additional Identifiers

Package DI Number

20699073704324

Quantity per Package

6

Contains DI Package

00699073704320

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