LibreLinkUp - LibreLinkUp - ABBOTT DIABETES CARE INC

Duns Number:966390890

Device Description: LibreLinkUp

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More Product Details

Catalog Number

72154-01

Brand Name

LibreLinkUp

Version/Model Number

72154-01

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

PJT

Product Code Name

Continuous glucose monitor secondary display

Device Record Status

Public Device Record Key

d8b7016d-1b4b-43fb-acb3-3c88b85d5087

Public Version Date

June 02, 2021

Public Version Number

1

DI Record Publish Date

May 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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