RAPIDPoint® 500 System 10492730

GUDID 00630414589169

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

Siemens Healthcare Diagnostics Inc.

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

• Primary Device ID: 00630414589169
• NIH Device Record Key: 2f96f239-486f-460e-89ee-5a93326c624f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAPIDPoint® 500 System
• Version Model Number: 10492730
• Catalog Number: 10492730
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414589169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113216

FDA Product Code

• KHP: ACID, LACTIC, ENZYMATIC METHOD

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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