GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 300 Tests)

GUDID 00195226000795

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (300 Tests, 31 days)

INSTRUMENTATION LABORATORY COMPANY

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

• Primary Device ID: 00195226000795
• NIH Device Record Key: 2607f655-1f3b-472f-a4e1-9f85d8676508
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 300 Tests)
• Version Model Number: 00077430009
• 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	00195226000795 [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

• 08430793242998 - HEMOSIL RIVAROXABAN CONTROLS: 2024-07-30 1. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vial
• 08430793243001 - HEMOSIL RIVAROXABAN CALIBRATORS: 2024-07-30 1. Rivaroxaban Calibrator 1 (Cat. No. 0020015410): 5 x 1mL vials 2. Rivaroxaban Calibrator 2 (Cat. No. 0020015420) : 5 x 1mL vi
• 00195226001129 - HemosIL Chromogenic Factor IX: 2024-07-17 HemosIL Chromogenic Factor IX
• 00195226000528 - ACL TOP 770: 2024-05-23 ACL TOP 770
• 00195226000535 - ACL TOP 770 LAS: 2024-05-23 ACL TOP 770 LAS
• 00195226000542 - ACL TOP 770s: 2024-05-23 ACL TOP 770s
• 00195226000559 - ACL TOP 570: 2024-05-23 ACL TOP 570
• 00195226000566 - ACL TOP 370: 2024-05-23 ACL TOP 370