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510(k) Data Aggregation
K Number
K131692Device Name
BLOSSOM SALINE DELIVERY ASSIST DEVICE
Manufacturer
Date Cleared
2014-07-10
(395 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MARZ MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indicated for assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.
Device Description
1. The Marz controller is a battery operated device that is used to assist the clinician in delivering sterile saline into a surgically placed sub-dermal temporary, removable tissue expander. The Marz Blossom Syringe Assist device includes a battery powered controller to provide a regulated method for delivery of a specific volume of saline at a specific rate. The Marz Medical Blossom Syringe Assist Device consists of a re-useable controller with an integrated syringe cradle for holding a 10cc syringe, firmware, LED displays, an external pressure sensor, and is battery powered by three 1.5V, AA batteries (LR6 designation).
2. Supplied with the controller in a kit are the following components: Single use, sterile 10cc luer lock piston syringe, transfer set with proximal connection to the controller, and saline reservoir including distal connections to the inflation port of the expander, or via an infusion needle. All connections are luer lock compatible. The fluid path is clear that allows for visual inspection of the content.
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