INOmax

GUDID 00810055285105

Injector Module, INOmax, BCG, CE 2797

Mallinckrodt Manufacturing LLC

Nitric oxide delivery unit, system-based

• Primary Device ID: 00810055285105
• NIH Device Record Key: b79c1f7f-1568-4c66-9531-2eabd089f49f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INOmax
• Version Model Number: 91359
• 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: 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(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 -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055285105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131686

FDA Product Code

• MRN: Apparatus, Nitric Oxide Delivery

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: 2023-02-09
• Device Publish Date: 2023-02-01

On-Brand Devices [INOmax]

• 10810055284280: LINE, MR PATIENT GAS SAMPLE & FILTER 16FT/5M BCG
• 10810055284150: Pack, Bunnell Life Pulse Disposable Adapters Convenience BCG, CE 2797
• 10810055284037: LINE, PATIENT GAS SAMPLE & FILTER 10FT/3M BCG, CE
• 10810055284020: FILTER ASSEMBLY, HYDROPHOBIC, CE
• 10810055283528: TUBE, NO/N2 INJECTOR BCG, CE 2797
• 10810055283481: LINE, PATIENT GAS SAMPLE, 10 FT/3 M WITH NAFION, BCG, CE
• 10810055283474: TEE, O2 TUBING SAMPLE BCG, CE 2797
• 10810055283443: Adapter, 22M/15F X 22M/15F BCG, CE 2797
• 10810055280886: ADAPTER, CUFF, 22mm ID X 22mm ID BCG, CE 2797
• 10810055280299: ADAPTER, CUFF, 22mm ID X 22mm ID BCG, CE 2797
• 00810055280285: ADAPTER, 22 mm OD X 10 mm OD BCG, CE 2797
• 00810055280278: ADAPTER, GAS SAMPLE TEE BCG
• 10810055280268: ADAPTER, 22M/15F X 22M/15F BCG
• 00810055280254: ADAPTER, 22F X 15M BCG
• 00810055285105: Injector Module, INOmax, BCG, CE 2797
• 00810055285099: INOmax Regulator ISO 5145 BOM (Right)
• 00810055285082: INOmax DSIR 800 ppm
• 00810055285075: INOblender NIST 800ppm
• 00810055285068: INOmax Transport Regulator/Cap ISO 5145 BOM
• 00810055285051: INOmax DSIR 400 ppm
• 00810055285044: Inomax transport regulator / cap assembly
• 00810055285037: INOblender NIST 400ppm
• 00810055285020: INOmax Regulator ISO 5145 BOM (Left)
• 00810055285013: INOmax Regulator Extension Hose
• 00810055285006: INOmax regulator CGA 626
• 00810055288458: CELL, NO2 FUEL
• 00810055288441: CELL, NO FUEL
• 10810055284174: PACK, SENSORMEDICS 3100A/B FILTERED CIRCUIT DISPOSABLE ADPTRS CNVC BCG, CE 2797
• 10810055283535: Adapter, 15M Fits 4.5 mm ID Tubing BCG, CE 2797
• 00810055283514: TEE, O2 TUBING SAMPLE, NO BUSHING BCG, CE 2797
• 10810055283504: Tube, MR NO/N2 Injector BCG
• 10810055283498: Disc Filter, Ø50mm, 1 micron glass fiber, BCG, CE
• 10810055283467: One-Way Valve, 22F X 22M
• 10810055283450: ADAPTER, 22F X 15M BCG, CE 2797
• 10810055283436: Adapter, Gas Sample Tee BCG, CE 2797
• 10810055281241: Extension, 15mm (6 inches) Pediatric
• 00810055280988: Tubing Kit,.187 X .312 X 10 Inch cut length, BCG, CE 2797
• 00810055280971: ADAPTER, 22 mm OD X 10 mm OD BCG, CE 2797
• 00810055280964: ADAPTER, 15M FITS 8.0 mm ID TUBING BCG, CE 2797
• 00810055280957: ADAPTER, 22M/15F X 22M/15F (POLYCARBONATE)
• 00810055280940: VALVE, ONE-WAY, HIGH FLOW FITS 3/8 in TUBING, BARBED ENDS
• 00810055280933: VALVE, HIGH FLOW ONE-WAY, 3/16 in TUBING, CE 2797
• 10810055280923: Line, 10ft patient gas sample BCG, CE
• 10810055280916: CARTRIDGE, INOvent WATER SEPARATOR, CE
• 10810055280909: ADAPTER, 22M/15F X 22M/15F GAS SAMPLE TEE, CE 2797
• 10810055280879: Adapter, 90-deg Sample Port BCG, CE 2797
• 10810055280862: Tubing, 10mm (2 pieces) Neonatal BCG
• 00810055280193: INOcal Regulator Accessory
• 00810055280186: INOcal Tubing Assembly
• 00810055280896: Extension, 15mm (6 inches) Pediatric