INOcal BOM-COM-0159

GUDID 00810055280025

INOcal 45 PPM NO Calibration Gas

Mallinckrodt Manufacturing LLC

Nitric oxide delivery unit, system-based

• Primary Device ID: 00810055280025
• NIH Device Record Key: 6d5cb41c-ebe7-4fa2-8dfb-2b8957994ec8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INOcal
• Version Model Number: BOM-COM-0159
• Catalog Number: BOM-COM-0159
• Company DUNS: 015322416
• Company Name: Mallinckrodt Manufacturing 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: true
• 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(877)566-9466
• Email: CritCare-csmail@mnk.com
• Phone: +1(877)566-9466
• Email: CritCare-csmail@mnk.com
• Phone: +1(877)566-9466
• Email: CritCare-csmail@mnk.com
• Phone: +1(877)566-9466
• Email: CritCare-csmail@mnk.com
• Phone: +1(877)566-9466
• Email: CritCare-csmail@mnk.com
• Phone: +1(877)566-9466
• Email: CritCare-csmail@mnk.com
• Phone: +1(877)566-9466
• Email: CritCare-csmail@mnk.com
• Phone: +1(877)566-9466
• Email: CritCare-csmail@mnk.com
• Phone: +1(877)566-9466
• Email: CritCare-csmail@mnk.com
• Phone: +1(877)566-9466
• Email: CritCare-csmail@mnk.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055280025 [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: 2022-07-26
• Device Publish Date: 2022-07-18

On-Brand Devices [INOcal]

• 00810055280056: INOcal 10 PPM NO2 Calibration Gas
• 00810055280025: INOcal 45 PPM NO Calibration Gas