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RAPIDPoint® 500 System

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
RAPIDPoint® 500 System FDA UDI
Generic Name
Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
Device Name
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 FDA UDI
Model / Reference
10492730 FDA UDI
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 FDA UDI

Identifiers

Catalog Number
10492730 FDA UDI
Primary DI / UDI-DI
00630414589169 FDA UDI
510(k) Number
K113216 FDA UDI
FDA Product Code
KHP FDA UDI
GMDN Term
Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood gas/haemoximetry analyser IVD, point-of-care

RAPIDPoint® 500 System by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood gas/haemoximetry analyser IVD, point-of-care.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 2f96f239-486f-460e-89ee-5a93326c624f 37 fields · synced Jun 8, 2026