Bionostic, Inc. Z03NI7543000001

GUDID 00819601025189

Description: 3.20% CO2, 21.80% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.

Airgas Therapeutics, LLC

Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder Calibration gas/refillable cylinder

• Primary Device ID: 00819601025189
• NIH Device Record Key: 87b756df-1abb-4ff7-8d6b-588edd685b9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bionostic, Inc.
• Version Model Number: Calibration Gas
• Catalog Number: Z03NI7543000001
• Company DUNS: 118537769
• Company Name: Airgas Therapeutics, 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

• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch
• Total Volume: 8300 Liter
• Pressure: 2400 Pound per Square Inch

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	00819601025189 [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: 2023-07-17
• Device Publish Date: 2023-07-07

On-Brand Devices [Bionostic, Inc.]

• 00819601025172: Description: 4% CO2, 10.80% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of med
• 00819601025165: Description: 4% CO2, 11.60% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of medi
• 00819601025158: Description: 4% CO2, 12.70% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of medi
• 00819601025141: Description: 6.20% CO2, 2.90% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of me
• 00819601025134: Description: 6.25% CO2, 7.3% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of med
• 00819601025127: Description: 6.9% CO2, 17% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of medic
• 00819601025264: Description: 99.999% ARGON; Cylinder: 300; Valve: CGA 580; For calibration of medical analyzer
• 00819601025257: Description: 99.9% NITROGEN; Cylinder: 300; Valve: CGA 580; For calibration of medical analyzer
• 00819601025240: Description: MEDICAL AIR; Cylinder: 300; Valve: CGA 346; For calibration of medical analyzers
• 00819601025233: Description: 0.40% CO2, 75% O2, BAL. N2; Cylinder: 300; Valve: CGA 296; For calibration of med
• 00819601025226: Description: 0.70% CO2, 48% O2, BAL. N2; Cylinder: 300; Valve: CGA 296; For calibration of medi
• 00819601025219: Description: 0.90% CO2, 21.8% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of m
• 00819601025202: Description: 2.20% CO2, 1.11% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of m
• 00819601025196: Description: 2.40% CO2, 19.70% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of
• 00819601025189: Description: 3.20% CO2, 21.80% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of