VKR-7

GUDID 00860003561959

Kit of QC material for the validation of sensor linear response in ABL800 series

RADIOMETER AMERICA INC.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

• Primary Device ID: 00860003561959
• NIH Device Record Key: 1a56ab93-a3db-44a9-b838-d40350381370
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VKR-7
• Version Model Number: VKR-7
• Company DUNS: 086661485
• Company Name: RADIOMETER AMERICA 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: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003561959 [Primary]

FDA Product Code

• JJS: Controls For Blood-Gases, (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

Devices Manufactured by RADIOMETER AMERICA INC.

• 10860003561901 - Safe PICO Kit: 2021-02-25 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd) Arterial bl
• 10860003561925 - Safe PICO Kit: 2021-02-25 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd) Arterial bl
• 00860003561904 - Safe PICO Kit: 2020-10-05 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd) Arterial bl
• 00860003561928 - safePICO: 2020-10-05 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd) Arterial bl
• 00860003561942 - VKR-5: 2020-10-05 Kit of QC material for the validation of sensor linear response in ABL90, ABL80 COOX, ABL80 COOX OSM series
• 00860003561959 - VKR-7: 2020-10-05Kit of QC material for the validation of sensor linear response in ABL800 series
• 00860003561959 - VKR-7: 2020-10-05 Kit of QC material for the validation of sensor linear response in ABL800 series
• 00860003561966 - VK-CREA: 2020-10-05 Kit of QC material for the validation of sensor linear response in ABL8X7 series
• 01860003561903 - safePICO: 2020-10-05 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd) Arterial bl