Catalog Number

-

Brand Name

OC-Auto

Version/Model Number

OCPUIO-WLS

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191147

Product Code

OOX

Product Code Name

Automated Occult Blood Analyzer

Public Device Record Key

8d56f20e-8d24-4497-9d14-6c0229af7cce

Public Version Date

December 28, 2021

Public Version Number

1

DI Record Publish Date

December 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-