Catalog Number

U-BZO-101

Brand Name

UCP Home

Version/Model Number

U-BZO-101

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K050540,K050540,K050540

Product Code

JXM

Product Code Name

Enzyme Immunoassay, Benzodiazepine

Public Device Record Key

166c4a24-1baf-4aaf-ad6a-afda18ad8096

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

December 05, 2016

Package DI Number

20817038021242

Quantity per Package

40

Contains DI Package

10817038021245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case