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510(k) Data Aggregation
K Number
K152362Device Name
Terumo SurGuard 3 Safety Hypodermic Needle
Manufacturer
TERUMO (PHILIPPINES) CORPORATION
Date Cleared
2015-10-16
(57 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
TERUMO (PHILIPPINES) CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Terumo SurGuard®3 Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Device Description
The Terumo SurGuard®3 Safety Hypodermic Needle [hereinafter referred to as "SurGuard 3 (Short Sheath 2)"] consists of a hypodermic needle with a hinged safety sheath attached to the connector hub which can be attached to either a luer slip or luer lock syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheathcollar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation, using the finger, thumb, or surface activation.
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K Number
K133280Device Name
TERUMO SURFLO I.V. CATHETER
Manufacturer
TERUMO (PHILIPPINES) CORPORATION
Date Cleared
2014-06-12
(230 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
TERUMO (PHILIPPINES) CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TERUMO® SURFLO® I.V. Catheter is inserted into the patient's vascular system for short term use (less than 30 days) to withdraw blood samples, monitor blood pressure, or administer fluids intravenously.
Device Description
The TERUMO® SURFLO® I.V. Catheter is a device consisting of a catheter assembly (catheter, caulking pin, and catheter hub) and needle assembly (needle, needle hub, filter cap and filter). The device is an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (<30days) use to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line.
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K Number
K121607Device Name
TERUMO(R) NEEDLE
Manufacturer
TERUMO (PHILIPPINES) CORPORATION
Date Cleared
2012-11-08
(160 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
TERUMO (PHILIPPINES) CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TERUMO® Needle is a hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Device Description
The TERUMO® NEEDLE is a hypodermic sterile single lumen needle, consisting of a stainless tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe or an intravascular administration set.
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K Number
K122249Device Name
TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE
Manufacturer
TERUMO (PHILIPPINES) CORPORATION
Date Cleared
2012-08-28
(32 days)
Product Code
FMI, 80F, MEG
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
TERUMO (PHILIPPINES) CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TERUMO® SurGuard®3 Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TERUMO SurGuard®3 Safety Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Device Description
The Terumo SurGuard 3 Safety Hypodermic Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheath-collar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath either by finger, thumb or surface activation.
The safety sheath has a finger guide area consisting of a circular dent (for thumb activation) and ramp (for finger activation) which gives the user a concrete confirmation that the user's finger is in the appropriate position in performing the activation. The ramp has steps to provide strong grasp when activating the sheath, There are two stoppers located at the end of the circular dent and ramp which prevent the user's finger from going towards the cannula during activation. Another method of activation is by manually pressing the safety sheath over the needle using a firm surface.
The locking mechanisms are positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner to flexibly adjust the sheath to its desired position for use.
The Terumo SurGuard 3 Safety Hypodermic Needle will be individually packaged and sterilized by electron beam as a safety needle only or as a safety needle with attached Terumo syringe.
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K Number
K113422Device Name
TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE
Manufacturer
TERUMO (PHILIPPINES) CORPORATION
Date Cleared
2012-03-05
(105 days)
Product Code
FMI, 80F, MEG
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
TERUMO (PHILIPPINES) CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TERUMO® SurGuard®3 Safety Needle device is intended for use in the aspiration and iniection of fluids for medical purposes. The TERUMO SurGuard 3 Safety Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Device Description
The TERUMO SurGuard®3 Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the sheath tooth-cannula and sheath wings-collar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath either by finger or thumb, or by surface activation.
The safety sheath has a finger guide area consisting of a circular dent (for thumb activation) and ramp (for finger activation) which gives the user a concrete confirmation that the user's finger is in the appropriate position in performing the activation. The ramp has steps to provide strong grasp when activating the sheath. There are two stoppers located at the end of the circular dent and ramp which assist in preventing the user's finger from going towards the cannula during activation. Another way of activation is by manually pressing the safety sheath over the needle using a firm surface.
The locking mechanisms are positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner to flexibly adjust the sheath to its desired position for use. The needle gauge sizes fall within the 18 to 25 gauge range and the needle lengths are 1" to 2".
The TERUMO SurGuard®3 Safety Needle will be individually packaged and sterilized by electron beam as a safety needle only or as a safety needle with attached Terumo syringe. The syringe sizes are 3, 5, and 10cc/ml.
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