FDA.reportPublic FDA data

Remunity

Primary DI
00850017421035
Brand
Remunity
Company
United Therapeutics Corporation
Model
DKPI-11042-001
Device description
STARTER KIT, PHARMACY FILL, UNITOne starter kit consists of:- (2) Pumps- (2) Remotes- (4) Batteries- (2) Chargers- (4) USB cables- (2) Charger adapters- (1) Quick Reference Guide- (1) User Guide- (2) Belt Clips
Published
2020-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJYInfusion Pump, Drug Specific, Pharmacy-Filled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJYInfusion Pump, Drug Specific, Pharmacy-FilledGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017421035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017421035008500174210358500174210350850017421035

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose infusion pump, battery-poweredA battery-powered ambulatory device intended to provide continuous or intermittent administration of non-specific drugs and/or solutions. It consists of a small unit with a pumping mechanism and an infusion-rate controller, and is used with a dedicated single-use medication cartridge (not included). It is used with a suitable 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 or carried in a pocket and may be used in a healthcare setting or in the home.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-864-8437drugsafety@unither.com
603-206-5091QA@millyardadvanced.com

Regulatory Flags#

DUNS number
015718364
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366302000231TyvasoTD-300/A2023-02-03
00850017421202RemunityPRODKUT-10007-0012025-08-07
00850017421219RemunityPRODKUT-10006-0012025-08-07
00850017421226RemunityPRODKUT-21134-0012025-08-07
00850017421233RemunityPRODKUT-11029-0072025-08-07
00850017421240RemunityPRODKUT-21073-0072025-08-07
00850017421264RemunityPRODKUT-21135-0012025-08-07
00850017421271RemunityPRODKUT-10008-0012025-08-07
00850017421042RemunityDKPI-11038-001DKPI-11038-0012021-02-11
00850017421097RemunityDKPI-21128-0012021-02-11
00850017421073RemunityDKPI-11036-0012020-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850017421042RemunityUnited Therapeutics CorporationQJY2021-02-11
00850017421097RemunityUnited Therapeutics CorporationQJY2021-02-11
00850017421073RemunityUnited Therapeutics CorporationQJY2020-12-11