RAPIDPoint® 500e Blood Gas System 11416751

GUDID 00630414286143

The RAPIDPoint® 500e Blood Gas System is a compact, bench-top analyzer designed for in vitro diagnostic testing and issuitable for professional use in a point-of-care or central laboratory environment. This system measures the following: blood gases,electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.Additionally, the RAPIDPoint 500e Blood Gas System measures pH in pleural fluid.

Siemens Healthcare Diagnostics Inc.

Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care
Primary Device ID00630414286143
NIH Device Record Key0383eb1d-dc90-423e-af96-0de4d8c5962f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAPIDPoint® 500e Blood Gas System
Version Model Number11416751
Catalog Number11416751
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414286143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JFPELECTRODE, ION SPECIFIC, CALCIUM

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-23
Device Publish Date2020-04-15

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Trademark Results [RAPIDPoint]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RAPIDPOINT
RAPIDPOINT
75611313 2397000 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
1998-12-23
RAPIDPOINT
RAPIDPOINT
75205421 2243214 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
1996-11-27

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