Catalog Number

2300000-004

Brand Name

CardioLab

Version/Model Number

AltiX

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

K213972

Product Code

DQK

Product Code Name

Computer, diagnostic, programmable

Public Device Record Key

3710b3d0-c026-49fc-8ebb-5825a5974637

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

May 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-