Catalog Number

01P0603

Brand Name

Alinity-Architect

Version/Model Number

01P0603

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080751,K070822,K070820,K070820,K070822,K080751

Product Code

MKW

Product Code Name

CYCLOSPORINE

Public Device Record Key

63d10d7e-b9da-422a-a37b-11a0c80a5835

Public Version Date

June 24, 2019

Public Version Number

1

DI Record Publish Date

June 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-