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510(k) Data Aggregation
K Number
K140442Device Name
MEDSOURCE SELECTABLE IV SET
Manufacturer
MEDSOURCE INTERNATIONAL, LLC.
Date Cleared
2014-04-22
(60 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MEDSOURCE INTERNATIONAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein
Device Description
Not Found
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K Number
K140402Device Name
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
Manufacturer
MEDSOURCE INTERNATIONAL, LLC.
Date Cleared
2014-04-03
(44 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MEDSOURCE INTERNATIONAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.
Device Description
Not Found
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K Number
K131555Device Name
MEDSOURCE IV SAFETY CATHETER
Manufacturer
MEDSOURCE INTERNATIONAL, LLC.
Date Cleared
2014-01-31
(247 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
MEDSOURCE INTERNATIONAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedSource IV Safety Catheter is indicated to sample blood or administer fluids intravenously. The MedSource IV Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
Device Description
The MedSource IV Safety Catheter is a safety medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse.
The device comprises a sharp needle attached to a hub which projects into a chamber. In the 'unactivated' state prior to insertion, the needle and hub are 'locked' in position. There exists a retraction mechanism for 'unlocking' the needle such that on activation of this mechanism it is withdrawn and completely enclosed within the chamber. This mechanism for retracting the needle preferably includes a coiled spring or other elastic components. The retraction mechanism is activated by the user using only one hand by means of a lever or 'switch'.
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K Number
K120424Device Name
MEDSOURCE IV ADMINSTRATION SET
Manufacturer
MEDSOURCE INTERNATIONAL, LLC.
Date Cleared
2012-07-11
(149 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MEDSOURCE INTERNATIONAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedSource IV Administration Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.
Device Description
The MedSource IV Administration Set is a sterile, single use intravascular administration set used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device includes: 1. Guard for Closure 2. Closure Piercing Device (spike)- Vented with Drip flow rate (either 10, 15, or 60 drops/mL 3. Housing for air-vent with filter 4. Drip Chamber 5. Fluid Filter 6. Tubing 7. Flow Regulator 8. Injection Site (Y-site, Needleless) 9. Male Luer Lock Fitting 10. Protective Cap for Male Fitting
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K Number
K080339Device Name
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
Manufacturer
MEDSOURCE INTERNATIONAL, LLC.
Date Cleared
2008-10-27
(262 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
MEDSOURCE INTERNATIONAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for Use: MedSource Endotracheal Tube: The device is intended for oral or nasal intubation and for airway management.
Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylet: The device is intended for oral or nasal intubation and for airway management.
Device Description
MedSource Pre-Loaded Endotracheal Tube (Cuffed & Uncuffed) with and without Stylet:
• Constructed of Polyvinylchloride
• Single lumen tube with or without a cuff;
• Tapered tip with Murphy Eye;
• Clear medical-grade tubing(polyvinyl) with graduations;
• Connector with check valve;
• Pre-loaded with Stylet having a low friction coating;
• Various sizes
• Sterile Single-Use Device
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K Number
K081516Device Name
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
Manufacturer
MEDSOURCE INTERNATIONAL, LLC.
Date Cleared
2008-08-26
(88 days)
Product Code
CBP
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
MEDSOURCE INTERNATIONAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques.
The CPR Mask with Oxygen Port is for prescription use.
Device Description
A one piece, single use, full-size, light-weight PVC mask system which includes:
- A Universal breathing tube.
- A One-way filtered valve.
- A Head strap.
- With Oxygen Port or Without Oxygen Port.
- Packaged for easy portability and quick access.
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