Remunity Pump For Remodulin (treprostinil) Injection

Infusion Pump, Drug Specific, Pharmacy-filled

DEKA Research And Development

The following data is part of a premarket notification filed by Deka Research And Development with the FDA for Remunity Pump For Remodulin (treprostinil) Injection.

Pre-market Notification Details

Device IDK202690
510k NumberK202690
Device Name:Remunity Pump For Remodulin (treprostinil) Injection
ClassificationInfusion Pump, Drug Specific, Pharmacy-filled
Applicant DEKA Research And Development 340 Commercial Street Manchester,  NH  03101
ContactPaul Smolenski
CorrespondentPaul Smolenski
DEKA Research And Development 340 Commercial Street Manchester,  NH  03101
Product CodeQJY  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-15
Decision Date2020-12-30

Trademark Results [Remunity Pump For Remodulin (treprostinil) Injection]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
88345768 not registered Live/Pending
United Therapeutics Corporation
2019-03-19
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