Catalog Number

03R8921

Brand Name

AlinIQ

Version/Model Number

03R89-21

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

-

Product Code

JQP

Product Code Name

CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Public Device Record Key

04e5860a-9f55-4fa7-b9cc-0fee484e2f8a

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

January 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-