Catalog Number

10255100

Brand Name

Animas Vibe

Version/Model Number

10255100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 21, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OYC

Product Code Name

Pump, infusion, insulin, to be used with invasive glucose sensor

Public Device Record Key

57c568be-b6b0-4a57-ac51-b426e6347dad

Public Version Date

August 04, 2021

Public Version Number

4

DI Record Publish Date

September 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-