GEM CVP (Calibration Validation Product) Level 4 00024001814

GUDID 08426950358763

GEM CVP (Calibration Validation Product) Level 4

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

• Primary Device ID: 08426950358763
• NIH Device Record Key: 2f3c7ca5-e277-4c87-8bbe-6664bb5c2f49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM CVP (Calibration Validation Product) Level 4
• Version Model Number: 00024001814
• Catalog Number: 00024001814
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Device Count: 20
• 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: false
• 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@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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950358763 [Primary]
GS1	18426950358760 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052121

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

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

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