RAPIDLab® 1200 Series 1245 - RAPIDLab 1200 systems are intended for in vitro - Siemens Healthcare Diagnostics Inc.

Duns Number:064608573

Device Description: RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1245 can determine pH, pCO2, pO2, tHb, nBili, FO2Hb, FCOHb, FMetHb, FHHb parameters

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More Product Details

Catalog Number

5061537

Brand Name

RAPIDLab® 1200 Series 1245

Version/Model Number

10321844

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

K031560

Product Code Details

Product Code

CEM

Product Code Name

ELECTRODE, ION SPECIFIC, POTASSIUM

Device Record Status

Public Device Record Key

8812a18b-774d-4256-a6ce-9adaa288a401

Public Version Date

November 19, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

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