Bionostic, Inc. Z03NI8243000001

GUDID 00819601024977

Description: 4% CO2, 13.2% O2, BAL. N2; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.

AIRGAS USA LLC

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• Primary Device ID: 00819601024977
• NIH Device Record Key: a3e6eaf5-704f-4949-851e-8c271fcd667a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bionostic, Inc.
• Version Model Number: Calibration Gas
• Catalog Number: Z03NI8243000001
• Company DUNS: 831996595
• Company Name: AIRGAS USA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com
• Phone: 1-800-233-4334
• Email: customerservice.healthcare@airliquide.com

Device Dimensions

• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8000 Liter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819601024977 [Primary]

FDA Product Code

• BXK: Gas, Calibration (Specified Concentration)

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: 2023-02-27
• Device Publish Date: 2023-02-17

On-Brand Devices [Bionostic, Inc.]

• 00819601024984: Description: 6.25% CO2, 5.88% O2, BAL. N2; Cylinder: K; Valve: CGA 500; For calibration of med
• 00819601024977: Description: 4% CO2, 13.2% O2, BAL. N2; Cylinder: K; Valve: CGA 500; For calibration of medica
• 00819601024960: Description: 6.25% CO2, 7.9% O2, BAL. N2; Cylinder: K; Valve: CGA 500; For calibration of medi