GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests)

GUDID 00195226000689

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (450 Tests, 31 days)

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies

• Primary Device ID: 00195226000689
• NIH Device Record Key: 87756e82-7789-4391-9e0a-929fc90e5641
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests)
• Version Model Number: 00077445011
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com
• Phone: 8006780710
• Email: techsupport.na@werfen.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195226000689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223608

FDA Product Code

• CHL: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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: 2023-10-10
• Device Publish Date: 2023-10-02

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

• 00195226000641 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests): 2023-10-11 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (300 T
• 00195226000627 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (600 T
• 00195226000634 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (450 T
• 00195226000658 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (150 T
• 00195226000665 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (75 Te
• 00195226000672 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 600 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2
• 00195226000689 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests): 2023-10-10GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (450 Tests, 31 days)
• 00195226000689 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2
• 00195226000696 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2