AccessGUDID - DEVICE: RAPIDPoint® 500e Blood Gas System (00630414286143)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDPoint® 500e Blood Gas System
Version or Model: 11416751
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11416751
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414286143
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CHL	Electrode measurement, blood-gases (pco2, po2) and blood ph
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED
CGA	GLUCOSE OXIDASE, GLUCOSE
KHP	ACID, LACTIC, ENZYMATIC METHOD

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192240	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0383eb1d-dc90-423e-af96-0de4d8c5962f
Public Version Date: November 19, 2021
Public Version Number: 3
DI Record Publish Date: April 15, 2020