AlinIQ - AlinIQ AMS - ABBOTT SRL

Duns Number:430747238

Device Description: AlinIQ AMS

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More Product Details

Catalog Number

03R8947

Brand Name

AlinIQ

Version/Model Number

03R89-47

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

JQP

Product Code Name

Calculator/data processing module, for clinical use

Device Record Status

Public Device Record Key

24bd425c-3f18-4374-9722-48a848c9bacc

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

March 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7