RemunityPRO

GUDID 00850017421226

RemunityPRO Cassette

United Therapeutics Corporation

Ambulatory non-insulin infusion pump, electronic

• Primary Device ID: 00850017421226
• NIH Device Record Key: 23f61863-3193-4097-a8c9-8b6279dd5e3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RemunityPRO
• Version Model Number: DKUT-21134-001
• Company DUNS: 015718364
• Company Name: United Therapeutics Corporation
• 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: 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: 877-864-8437
• Email: drugsafety@unither.com
• Phone: 877-864-8437
• Email: drugsafety@unither.com
• Phone: 877-864-8437
• Email: drugsafety@unither.com
• Phone: 877-864-8437
• Email: drugsafety@unither.com
• Phone: 877-864-8437
• Email: drugsafety@unither.com
• Phone: 877-864-8437
• Email: drugsafety@unither.com
• Phone: 877-864-8437
• Email: drugsafety@unither.com
• Phone: 877-864-8437
• Email: drugsafety@unither.com
• Phone: 877-864-8437
• Email: drugsafety@unither.com
• Phone: 877-864-8437
• Email: drugsafety@unither.com
• Phone: 877-864-8437
• Email: drugsafety@unither.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017421226 [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: 2025-08-15
• Device Publish Date: 2025-08-07

On-Brand Devices [RemunityPRO]

• 00850017421271: RemunityPRO Pump / Remote Replacement Kit contains one RemunityPRO Pump and one RemunityPRO Remo
• 00850017421264: RemunityPRO Remote Interface
• 00850017421240: RemunityPRO Pump
• 00850017421233: RemunityPRO Starter Kit contains 2 pumps, 2 remote interfaces, chargers, batteries, and Instruct
• 00850017421226: RemunityPRO Cassette
• 00850017421219: RemunityPRO Cassette Pack contains 10 RemunityPRO Cassettes
• 00850017421202: RemunityPRO Cassette Overpack contains 24x DKUT-10006-001 RemunityPRO Cassette Pack