ADVIA 2120i Refurb w/o Autosampler - ADVIA 2120i Refurbished System, Without - Siemens Healthcare Diagnostics Inc.

Duns Number:064608573

Device Description: ADVIA 2120i Refurbished System, Without Autosampler

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More Product Details

Catalog Number

11314046

Brand Name

ADVIA 2120i Refurb w/o Autosampler

Version/Model Number

11314046

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)

-

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

GKZ

Product Code Name

Counter, differential cell

Device Record Status

Public Device Record Key

9b9b8740-6f1c-432e-b3d4-e7351302bef9

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

July 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE DIAGNOSTICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 363
2 A medical device with a moderate to high risk that requires special controls. 829
3 A medical device with high risk that requires premarket approval 57
U Unclassified 7