Catalog Number

MobiCT-32

Brand Name

Airo®

Version/Model Number

MobiCT-32

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

K131431,K131431

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

28e8914d-87ef-43cb-bbc5-fef818c7e858

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Package DI Number

10869346000207

Quantity per Package

1

Contains DI Package

00869346000200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Crate