On-body Infusor for Furoscix®

GUDID 00371767000009

A wearable, single-use, electromechanical (battery powered, micro-processor controlled), on-body delivery system that is pre-programmed to deliver 80 mg of FUROSCIX over 5-hours using a bi-phasic delivery profile.

Scpharmaceuticals Inc.

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• Primary Device ID: 00371767000009
• NIH Device Record Key: 09c7ff39-9242-4904-b30b-53edc3fc08e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On-body Infusor for Furoscix®
• Version Model Number: DWG-0189
• Company DUNS: 079386513
• Company Name: Scpharmaceuticals Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• 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: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx
• Phone: 1-855-727-4276
• Email: xx@xx.xx

Device Dimensions

• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter
• Length: 116 Millimeter
• Width: 61 Millimeter
• Height: 30 Millimeter

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00371767000009 [Primary]

FDA Product Code

• FRN: Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-29
• Device Publish Date: 2023-09-21