Abbott - Abbott Diabetes Care USB Data Cable Software - ABBOTT DIABETES CARE INC

Duns Number:966390890

Device Description: Abbott Diabetes Care USB Data Cable Software

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More Product Details

Catalog Number

70851

Brand Name

Abbott

Version/Model Number

70851

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

OUG

Product Code Name

Medical device data system

Device Record Status

Public Device Record Key

6b64c1b2-8adf-498c-bce4-e11bd8a46d83

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 15, 2021

Additional Identifiers

Package DI Number

30699073708510

Quantity per Package

40

Contains DI Package

00699073708519

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