INOmax DSIR Plus MRI

GUDID 00867538000113

INOmax DSIR Plus MRI

Mallinckrodt Manufacturing LLC

Nitric oxide delivery unit, system-based

• Primary Device ID: 00867538000113
• NIH Device Record Key: e29679e0-400f-41be-bfee-d4f721f20620
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INOmax DSIR Plus MRI
• Version Model Number: 10074
• Company DUNS: 828331780
• Company Name: Mallinckrodt Manufacturing LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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@mallinckrodt.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867538000113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143213

FDA Product Code

• MRO: APPARATUS, NITRIC OXIDE, BACKUP DELIVERY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-11

Devices Manufactured by Mallinckrodt Manufacturing LLC

• 00810055280063 - INOmax: 2024-04-08 Evolve System Assembly US
• 00810055280070 - INOmax: 2024-04-08 Evolve Cart US
• 00810055280087 - INOmax: 2024-04-08 Evolve Injector Module
• 00810055280094 - INOmax: 2024-04-08 Evolve eINOcal Module
• 10810055280107 - INOmax: 2024-04-08 EVOLVE PRE-USE CHECKOUT KIT, BCG
• 10810055280114 - INOmax: 2024-04-08 Evolve Bunnell Life Pulse Conv Pack with Natvar
• 10810055280138 - INOmax: 2024-04-08 Evolve Sensormedics 3100A/B UnFiltered Conv Pac
• 10810055280145 - INOmax: 2024-04-08 Evolve Injector Tube