Catalog Number

10995550

Brand Name

Atellica IM Multi-Diluent 12

Version/Model Number

10995550

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K071455

Product Code

MKW

Product Code Name

CYCLOSPORINE

Public Device Record Key

c12b0c6c-c2c9-49b7-8045-9be441b11cf8

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

February 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-