GEM Premier 5000 PAK BG/COOX 300 TEST 00055430004

GUDID 08426950807711

GEM Premier 5000 PAK pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days

INSTRUMENTATION LABORATORY COMPANY

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

• Primary Device ID: 08426950807711
• NIH Device Record Key: 23830116-132f-4c2a-868b-80acf084090f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM Premier 5000 PAK BG/COOX 300 TEST
• Version Model Number: 00055430004
• Catalog Number: 00055430004
• 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: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com
• Phone: 1(800)678-0710
• Email: techsupport.na@werfen.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *STORE at 15-25 Degree C DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950807711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160415
• Premarket Notification: K173403

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-07-12
• Device Publish Date: 2018-01-24

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