Catalog Number

-

Brand Name

Fully Automated Urine Particle Analyzer UF-1000i

Version/Model Number

05366719

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

K961054

Product Code

LKM

Product Code Name

COUNTER, URINE PARTICLE

Public Device Record Key

7efdff80-5965-4edb-9e2a-a3a38f682487

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

August 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-