Catalog Number

10012402

Brand Name

Animas 2.0 mL Cartridge

Version/Model Number

10012402

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

Yes

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

OYC

Product Code Name

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

Public Device Record Key

3b92e296-1dd2-4a0e-bf3f-ebc977951bb7

Public Version Date

August 04, 2021

Public Version Number

4

DI Record Publish Date

September 17, 2015

Package DI Number

10840406100129

Quantity per Package

10

Contains DI Package

10840406100136

Package Discontinue Date

July 21, 2020

Package Status

Not in Commercial Distribution

Package Type

-