RAPIDPoint® 500e Blood Gas System

Basic Information

• Brand Name: RAPIDPoint® 500e Blood Gas System
• Primary DI: 00630414286143
• Version / Model: 11416751
• Catalog Number: 11416751
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-15
• Public Version: 3
• Public Version Date: 2021-11-19
• Public Version Status: Update
• Public Device Record Key: 0383eb1d-dc90-423e-af96-0de4d8c5962f

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2
CHL	Electrode measurement, blood-gases (pco2, po2) and blood ph	Clinical Chemistry	862.1120	2
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM	Clinical Chemistry	862.1113	1
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED	Hematology	864.5620	2
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
KHP	ACID, LACTIC, ENZYMATIC METHOD	Clinical Chemistry	862.1450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56672	Blood gas/haemoximetry analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414286143	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K192240	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 40 Degrees Celsius