FDA.reportPublic FDA data

RAPIDPoint® 500 System

Primary DI
00630414589169
Brand
RAPIDPoint® 500 System
Company
Siemens Healthcare Diagnostics Inc.
Model
10492730
Catalog number
10492730
Device description
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, FO2Hb, FCOHb, FMetHb, FHHb, nBili
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHPACID, LACTIC, ENZYMATIC METHOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113216000RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare Diagnostics2012-05-03KHP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414589169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414589169006304145891696304145891690630414589169

GMDN Terms#

Term, Definition table
TermDefinition
Blood gas/haemoximetry analyser IVD, point-of-careA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Serial number
true

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Primary DI, Brand, Company table
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