GEM 4000 PAK BG ISE COOX 450 TEST 30 DAY 00027445008

GUDID 08426950446224

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 450 Test 30DAY

INSTRUMENTATION LABORATORY COMPANY

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

• Primary Device ID: 08426950446224
• NIH Device Record Key: af31ebc4-2615-4943-9a2f-2e9e147a1dc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM 4000 PAK BG ISE COOX 450 TEST 30 DAY
• Version Model Number: 00027445008
• Catalog Number: 00027445008
• 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: false
• 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.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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag 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°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950446224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112995

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: 2021-07-08
• Device Publish Date: 2016-09-23

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