Catalog Number

60003

Brand Name

Unyvero

Version/Model Number

C8 Cockpit

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

-

Product Code

QBH

Product Code Name

Lower respiratory microbial nucleic acid detection system

Public Device Record Key

f957d17a-83e4-4478-bf7d-60d30f874149

Public Version Date

September 12, 2018

Public Version Number

2

DI Record Publish Date

May 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-