Remunity DKPI-11038-001

GUDID 00850017421042

DKPI-11038-001 (Training Kit) consists of a package containing the following: - Charger Assembly x1 - Dual USB Adapter x 1 - USB Cable x1 - Battery x2

United Therapeutics Corporation

General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered General-purpose infusion pump, battery-powered Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic
Primary Device ID00850017421042
NIH Device Record Key737e1301-a54d-4099-b6bd-21897f567a30
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemunity
Version Model NumberDKPI-11038-001
Catalog NumberDKPI-11038-001
Company DUNS015718364
Company NameUnited Therapeutics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com
Phone603-206-0591
EmailInfo@millyardadvanced.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017421042 [Primary]

FDA Product Code

QJYInfusion Pump, Drug Specific, Pharmacy-Filled

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-19
Device Publish Date2021-02-11

On-Brand Devices [Remunity]

00850017421073OVER PACK, DISPOSABLE KIT, UNITY 00850017421073 package contains: 10 packs of 12ea. disposable r
00850017421035STARTER KIT, PHARMACY FILL, UNIT One starter kit consists of: - (2) Pumps - (2) Remotes - (4) Ba
00850017421097DKPI-21128-001 SPECIALTY PHARMACY ACCESSORY KIT 00850017421097 is one package containing: - (12
00850017421042DKPI-11038-001 (Training Kit) consists of a package containing the following: - Charger Assembly

Trademark Results [Remunity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REMUNITY
REMUNITY
87275951 not registered Live/Pending
United Therapeutics Corporation
2016-12-21

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