Remunity
GUDID 00850017421035
STARTER KIT, PHARMACY FILL, UNIT One 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
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 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 ID | 00850017421035 |
| NIH Device Record Key | b023d15d-c447-4083-a76e-9019df106bbb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Remunity |
| Version Model Number | DKPI-11042-001 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com | |
| Phone | 877-864-8437 |
| drugsafety@unither.com |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017421035 [Primary] |
FDA Product Code
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-21 |
| Device Publish Date | 2020-12-11 |
On-Brand Devices [Remunity]
| 00850017421073 | OVER PACK, DISPOSABLE KIT, UNITY 00850017421073 package contains: 10 packs of 12ea. disposable r |
| 00850017421035 | STARTER KIT, PHARMACY FILL, UNIT One starter kit consists of: - (2) Pumps - (2) Remotes - (4) Ba |
| 00850017421097 | DKPI-21128-001 SPECIALTY PHARMACY ACCESSORY KIT 00850017421097 is one package containing: - (12 |
| 00850017421042 | DKPI-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 87275951 not registered Live/Pending |
United Therapeutics Corporation 2016-12-21 |
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