RemunityPRO

Basic Information

• Brand Name: RemunityPRO
• Primary DI: 00850017421219
• Version / Model: DKUT-10006-001
• Company Name: United Therapeutics Corporation
• Labeler DUNS: 015718364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-07
• Public Version: 1
• Public Version Date: 2025-08-15
• Public Version Status: New
• Public Device Record Key: 2e537edc-8f02-46fe-805e-b02c29049a20

Device Description

RemunityPRO Cassette Pack contains 10 RemunityPRO Cassettes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRN	Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61514	Ambulatory non-insulin infusion pump, electronic	A battery-powered ambulatory device intended to provide continuous or intermittent administration of medication, commonly for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA); it is not dedicated to insulin infusion. It consists of a small unit with a pumping mechanism and an infusion-rate controller. It is used with a dedicated single-use medication cartridge and/or an injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt, carried in a pocket or bag, for ambulation within and outside healthcare settings; it may be designed for optional pole mounting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850017421219	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius