GEM CVP (Calibration Valuation Product) 3 Hematocrit 00025000130

GUDID 08426950446231

GEM CVP (Calibration Valuation Product) 3 Hematocrit

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

• Primary Device ID: 08426950446231
• NIH Device Record Key: ce8a6b78-9ff2-4b43-bacf-6445549b1db8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM CVP (Calibration Valuation Product) 3 Hematocrit
• Version Model Number: 00025000130
• Catalog Number: 00025000130
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Device Count: 10
• 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.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 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950446231 [Primary]
GS1	18426950446238 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112995

FDA Product Code

• GLK: CONTROL, HEMATOCRIT

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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