Catalog Number

-

Brand Name

Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software

Version/Model Number

UF-1000i with UF WAM

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

K080887

Product Code

LKM

Product Code Name

COUNTER, URINE PARTICLE

Public Device Record Key

2a99a7ea-493b-4efe-8777-2aba62fc0430

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

August 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-