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510(k) Data Aggregation
K Number
K142527Device Name
Extension Set with BD Q-Syte Luer Access Split Septum
Manufacturer
ACACIA, INC.
Date Cleared
2014-09-19
(11 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
ACACIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-Power Injectable:
Extension Sets with an attached BD Q-Syte™ Luer Access Split Septum are intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.
Power Injectable:
The Power Injectable Extension Set with an attached BD Q-Syte™ Luer Access Split Septum is intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.
The Power Injectable Extension Set is also indicated for use with intravascular catheters indicated for power injection of contrast media. The Power Injectable Extension Set is suitable for use with power injectors set to a maximum pressure of 325 psi (2,240 kPa) when the BD Q-Syte device is removed and a direct connection is made.
Device Description
The Extension Sets with BD Q-Syte™ Luer Access Split Septum consist of a length(s) of flexible non-DEHP PVC clear tubing with a non-removable slide clamp. The devices include an ISO male Luer lock connection with a protection cap on the distal end an ISO female Luer lock connection on the proximal end(s) with a removable BD Q-Syte device or end cap. The Extension Sets with BD Q-Syte™ Luer Access Split Septum are provided in lengths from 5 in (127 mm) to 21 in (533 mm) with tubing diameters ranging from 0.035 in ID (0.89 mm) x 0.094 in OD (2.40 mm) to 0.110 in ID (2.80 mm) x .161 in OD (4.10 mm). Select Extension Sets include injection sites with a permanently attached BD Q-Syte device. The BD Q-Syte device is a needleless access device provided to aid in reducing the risk of accidental needlestick injuries. The Extension Sets with BD Q-Syte™ Luer Access Split Septum do not contain natural rubber latex.
The Power Injectable Extension Set with BD Q-Syte™ Luer Access Split Septum is suitable for use with power iniectors set to a maximum of 325 psi (2,240 kPa) when the BD Q-Syte device is removed and a direct connection is made. This device has a label attached to the tubing stating "Power Injectable Max 325 PSI".
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K Number
K122449Device Name
ENTERAL NUTRITION WARMER
Manufacturer
ACACIA, INC.
Date Cleared
2013-06-13
(304 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ACACIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7mL/min.
Device Description
The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the outside of the administration set tubing. The warmer includes an LED light to indicate the warmer is operating and a switch that will turn the warmer on and off. The Enteral Nutrition Warmer is reusable and provided non-sterile.
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K Number
K111381Device Name
MEDI-SIS SYRINGE INFUSION SYSTEM
Manufacturer
ACACIA, INC.
Date Cleared
2012-01-13
(241 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ACACIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1.0 The Medi-SIS Syringe Infusion System is indicated for the delivery of enteral fluids through clinically accepted routes of administration.
2.0 The Medi-SIS Administration Extension Set is intended for single patient use only.
3.0 The Medi-SIS Syringe Driver can be reused up to 5,000 times
Device Description
The Medi-SIS Syringe Infusion System consists of a Syringe Driver (mechanical syringe pump), proprietary administration extension set, and compatible syringe.
The Medi-SIS Syringe Driver consists of a mechanical syringe pump assembly that is manufactured from plastic housings and end caps, and steel spring (mechanical force from the spring presses against the syringe plunger), and holds a 30mL or 60mL Becton Dickinson syringe (preamendment device) or a 30mL or 60mL Acacia syringe (K092986). The Medi-SIS Syringe Driver must be used in conjunction with a Medi-SIS Administration Extension Set, which controls the time the infusion will occur (by flow restrictor) for the entire volume of the filled syringe. The Medi-SIS Syringe Infusion System infuses fluids in a continuously decreasing rate and the user can calculate the average flow rate based from volume and time infused.
The Medi-SIS Syringe Driver is reusable and provided non-sterile.
The Medi-SIS Administration Set consists of various lengths of flexible non-DEHP PVC tubing. on/off clamp, flow restrictor, and male and female connectors. The male and female connectors meet Acacia's internal specifications for enteral applications to ensure cross connections do not occur between IV and Enteral infusions. Additional componentry may be added and configurations modified based on the needs of clinicians.
The following Administration Extension Sets will be available:
60mL Syringe Size, 1.0mL per minute delivery rate 60mL Syringe Size, 2.0mL per minute delivery rate 30mL Syringe Size, 0.5mL per minute delivery rate 30mL Syringe Size, 1.0mL per minute delivery rate 30mL Syringe Size. 2.0mL per minute delivery rate
The approximate residual volume for the syringe/administration set combination is approximately 2.20mL for all configurations. The Medi-SIS Administration Extension Set is provided sterile, single use, and non-pyrogenic.
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K Number
K103165Device Name
BLOOD SAMPLING SET
Manufacturer
ACACIA, INC.
Date Cleared
2010-11-10
(14 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
ACACIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blood Sampling Set is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Device Description
The Blood Sampling Set consists of non-DEHP PVC tubing, and configured with one or more stopcocks with needleless valves, and a male luer lock for connection with the patients catheter. An optional configuration includes check valves, non-DEHP PVC tubing and transfer spike to allow for withdrawing flush solution from an IV bag into a syringe. All sets can be ordered with a choice of various on/off clamps, depending on the clinician's and hospital protocol. The Blood Sampling Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.
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K Number
K092986Device Name
ACACIA PISTON SYRINGE
Manufacturer
ACACIA, INC.
Date Cleared
2009-10-27
(29 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ACACIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Acacia Piston Syringe is indicated for the injection of fluids into, or withdrawal fluids from, the body. It is also used as a dispenser, a measuring device, and a fluid transfer device.
Device Description
The Acacia Piston Syringe consists of a calibrated hollow cytincrical body and movable plunger. At the tip of the barrel is a tapered male connector, which can be in a luer lock, luer slip, oral lock, and oral slip configurations.
The Acacia Piston Syringe can also be used as a dispenser without the use of a plunger.
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K Number
K972538Device Name
FLOW-EZE BLUNT CANNULA (1999BC)
Manufacturer
ACACIA, INC.
Date Cleared
1998-07-15
(372 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
ACACIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ACACIA'S Flow Eze Blunt Cannula for use with a sterile Acacia 3 riow mac bean medication into a Baxter's Interlink ) Injece meaze Blunt Cannula is single-use only. Split Septum.
Device Description
Not Found
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