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RAPIDPoint® 500e Blood Gas System

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
RAPIDPoint® 500e Blood Gas System FDA UDI
Generic Name
Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
Device Name
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. FDA UDI
Model / Reference
11416751 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
11416751 FDA UDI
Primary DI / UDI-DI
00630414286143 FDA UDI
510(k) Number
K192240 FDA UDI
FDA Product Code
JFP FDA UDI
JGS FDA UDI
CHL FDA UDI
CGZ FDA UDI
MQM FDA UDI
CEM FDA UDI
GKR FDA UDI
CGA FDA UDI
KHP FDA UDI
GMDN Term
Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1145 FDA UDI
862.1665 FDA UDI
862.1120 FDA UDI
862.1170 FDA UDI
862.1113 FDA UDI
862.1600 FDA UDI
864.5620 FDA UDI
862.1345 FDA UDI
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

Yes

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

Yes

FDA UDI

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

RAPIDPoint® 500e Blood Gas System by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K192240 also covers:

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 0383eb1d-dc90-423e-af96-0de4d8c5962f 37 fields · synced May 31, 2026