CEN/180 MYO DILUENT - Myoglobin Diluent - CENTAUR - CONS - 1x10mL - Siemens Healthcare Diagnostics Inc.

Duns Number:064608573

Device Description: Myoglobin Diluent - CENTAUR - CONS - 1x10mL

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More Product Details

Catalog Number

112370

Brand Name

CEN/180 MYO DILUENT

Version/Model Number

10310033

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

Yes

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

GIF

Product Code Name

DILUENT, BLOOD CELL

Device Record Status

Public Device Record Key

a7c12721-234e-49ab-a1f2-639f080addee

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

December 01, 2018

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