Search Results
Found 2 results
510(k) Data Aggregation
K Number
K234129Device Name
Ecomed Disposable Administration Sets
Manufacturer
Ecomed Solutions, LLC
Date Cleared
2024-09-20
(267 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Ecomed Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ecomed Disposable Administration sets are used to transfer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
Device Description
The Ecomed Disposable Administration Sets are a family of sterile, single use gravity sets composed of common components that are used to administer fluids. Each set is comprised of a subset of common components which are broadly used throughout industry including roller clamp, slide clamp, a flow regulator, a drip chamber, an infusion line filter, fluid delivery tubing, Burette w/ needle-free injection site and vent/cap and drip chamber 60 drop, injection site, connectors between parts of the set, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. This family of sets and components is broken down into the following main categories: Primary set, Tee set, Flow Controller Set, Filter Set, and Burette Set.
Ask a Question
K Number
K162088Device Name
Ecomed Disposable Angiographic Syringes
Manufacturer
ECOMED SOLUTIONS, LLC
Date Cleared
2017-01-27
(183 days)
Product Code
DXT
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
ECOMED SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is a family of Angiographic Syringes for the injection of contrast media and saline. The syringe is for single use with US legally marketed angiographic injectors.
Device Description
The Ecomed Disposable Angiographic Syringes are disposable syringes for use with contrast delivery systems that deliver contrast media or saline into the vascular system for the purpose of obtaining enhanced diagnostic images. The syringes are available in several sizes and configurations to ensure compatibility with US legally marketed contrast delivery systems.
The syringes are provided in kits that are configured from the following list of components:
- . Syringe(s)
- . Fill tube
- Vial Spike (small/large)
- . Transfer tubing set (length, y vs straight)
Ask a Question
Page 1 of 1