Catalog Number

VF-15552-E

Brand Name

ARROW

Version/Model Number

IPN001187

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141051,K141051,K141051

Product Code

MDS

Product Code Name

Sensor, glucose, invasive

Public Device Record Key

9f05adf1-fb6a-4f48-8211-e647f8042aae

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

April 20, 2016

Package DI Number

20801902112785

Quantity per Package

1

Contains DI Package

30801902112782

Package Discontinue Date

February 26, 2018

Package Status

Not in Commercial Distribution

Package Type

Case