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

GUDID 00195226000887

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, 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

• Primary Device ID: 00195226000887
• NIH Device Record Key: 5b1b0b85-713f-4806-af1d-4cc6f81c163b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 450 Tests)
• Version Model Number: 00077445005
• 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	00195226000887 [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