Catalog Number

991-60301

Brand Name

uTASWako i30

Version/Model Number

991-60301

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

K100464,K100464

Product Code

OUE

Product Code Name

Micro Total Analysis Instrument System

Public Device Record Key

747bb4d8-075b-4dae-bb3c-6fe3fd51a5d9

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

October 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-