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510(k) Data Aggregation
K Number
K023595Device Name
BURETTE-IN LINE (150 ML)
Manufacturer
TUTA HEALTHCARE PTY LIMITED
Date Cleared
2002-12-18
(51 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
TUTA HEALTHCARE PTY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Administration of Intravenous fluids and drugs. The Tuta Healthcare Pty. Burette In Line (150ml) is a device used to administer fluids from a container to a patient's vascular system Through a cannula inserted into a vein.
Device Description
The Tuta Healthcare Burette - In Line (150 mL) is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient. The design of the Burette - In Line (150 mL) and Baxter Healthcare's In-Line Buretrol Extension Set are similar in terms of components of , PVC tubing, roller regulators and perforators.
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K Number
K023039Device Name
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
Manufacturer
TUTA HEALTHCARE PTY LIMITED
Date Cleared
2002-11-07
(56 days)
Product Code
BRZ
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
TUTA HEALTHCARE PTY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Administration of Intravenous fluids and drugs.
The Tuta Healthcare Pty. Limited Blood Administration Set is a device used to administer fluids, blood and blood products from a container to a patient's vascular system Through a catheter or venous access system inserted into a vein.
Use of Needle-Free Access site may aide in the prevention of needlestick injury.
Device Description
The Tuta Healthcare Blood/Solution Administration Set is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient.
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K Number
K020083Device Name
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
Manufacturer
TUTA HEALTHCARE PTY LIMITED
Date Cleared
2002-02-12
(33 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
TUTA HEALTHCARE PTY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system for fluid management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).
Device Description
The Tuta Healthcare Arthroscopy Flushing set is designed to provide controlled Irrigation to a joint during arthroscopic procedures. action of the hand pump help to remove blood, tissue debris, loose bodies and foreign matter from the joint cavity. The click clamps are used to block the flow of fluid.
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