Catalog Number

ATW-2

Brand Name

IOPS™

Version/Model Number

ATW-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190106,K190106

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Public Device Record Key

36c82a63-f3fc-4488-80b3-ee97d05bf9cc

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 18, 2020

Package DI Number

10843152102034

Quantity per Package

5

Contains DI Package

00843152102037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box