FreeStyle Precision Neo - FreeStyle Precision Neo Blood Glucose Test Strips - ABBOTT DIABETES CARE INC

Duns Number:966390890

Device Description: FreeStyle Precision Neo Blood Glucose Test Strips

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More Product Details

Catalog Number

71750

Brand Name

FreeStyle Precision Neo

Version/Model Number

71750

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

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

K171941,K171941,K171941

Product Code Details

Product Code

NBW

Product Code Name

SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Device Record Status

Public Device Record Key

96615284-4f10-4ac4-b0fd-7a225fcd03da

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

April 13, 2018

Additional Identifiers

Package DI Number

30357599000357

Quantity per Package

6

Contains DI Package

00357599000356

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