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Found 13 results
510(k) Data Aggregation
K Number
K110656Device Name
IMC BLOOD COLLECTION NEEDLE
Manufacturer
INTERNATIONAL MEDSURG CONNECTION
Date Cleared
2011-08-18
(164 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDSURG CONNECTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use in venous blood collection.
Device Description
This device is intended for use in venous blood collection.
IMC blood collection needles are manufactured from stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is shorter end and is fitted with a protective rubber sleeve. And a needle cap. The opposite end of the needle is 1" or 1 ½" for withdrawing blood. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity.
IMC blood collection needles are a sterile single use disposable product. The needles are nontoxic and non-pyrogenic and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1 ½').
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K Number
K110882Device Name
IMC INSULIN SYRINGE
Manufacturer
INTERNATIONAL MEDSURG CONNECTION
Date Cleared
2011-08-18
(141 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDSURG CONNECTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for the subcutaneous injection of insulins.
Device Description
This device is consisting of barrel, plunger, piston, cannula (which is tixed in the barrel nozzle lumen), top cap and cannula cap (orange color) with different gauges and cannula length.
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K Number
K102584Device Name
IMC HYPODERMIC NEEDLE
Manufacturer
INTERNATIONAL MEDSURG CONNECTION
Date Cleared
2011-01-14
(128 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDSURG CONNECTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
Device Description
This device is consist of hub, cannula and protector and has difference hub color per each of gauges.
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K Number
K102969Device Name
IMC PISTON SYRINGES
Manufacturer
INTERNATIONAL MEDSURG CONNECTION
Date Cleared
2010-12-20
(75 days)
Product Code
FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDSURG CONNECTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
International Medsurg Connection's piston syringe is intended for the injection of fluids into, or withdraw of fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger. The intended use is the same as the intended use on IMC piston syringe sold by International Medsurg Connection, Reference K022159.
This submission includes piston syringe that will be sold both sterile and non-sterile syringes are to be sold to OEMs for EtO sterilization according to their validated process per ANSVAMMISO 11135. Sterile syringes are to be sold directly to users after EO sterilization validation per ANSVAMMI/ISO 11135
Device Description
The device consists of a calibrated hollow barrel and a movable plunger with piston. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into or withdraw fluids from, the body.
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K Number
K100991Device Name
IMC SURGICAL DRAPE
Manufacturer
INTERNATIONAL MEDSURG CONNECTION
Date Cleared
2010-10-05
(179 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDSURG CONNECTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile.
Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSIIAMMIIISO 11135. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSIIAMMIIISO 11135
Device Description
The IMC Surgical Drape devices are patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is made of non-latex rubber.
The Bladder Suspension Drape, the GYN Drape and the TUR drape have the same features and same materials but have different dimension of drape and aperture.
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K Number
K100846Device Name
IMC SURGICAL FACE MASK
Manufacturer
INTERNATIONAL MEDSURG CONNECTION
Date Cleared
2010-08-16
(144 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDSURG CONNECTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Device Description
The IMC Surgical Face Mask devices are surgical apparel intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The surgical masks feature either tie-on or ear loop attachment mechanisms. This device is a flat pleated 3 ply mask. The inner and outer layer of the mask is made of polypropylene, sandwiching a middle layer made of melt-blown polypropylene filter media. The outer layer of the mask is offered in a yellow color.
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K Number
K100208Device Name
IMC SURGICAL DRAPE
Manufacturer
INTERNATIONAL MEDSURG CONNECTION
Date Cleared
2010-04-20
(85 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDSURG CONNECTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.
Device Description
International Medsurg Connection's Surgical Drape is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures. This submission includes drapes that will be sold both sterile and non-sterile. Non-sterile drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile drapes are to be sold directly to users according to current sterilization process.
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K Number
K052169Device Name
IMC SURGICAL DRAPES
Manufacturer
INTERNATIONAL MEDSURG CONNECTION, INC.
Date Cleared
2005-11-17
(100 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDSURG CONNECTION, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.
Device Description
Surgical Drapes including various sizes and configurations of table covers, flat drape sheets, Lap drapes, cardiovascular drapes, head & neck drapes, general use drapes, cysto drapes, c-section drapes, orthopedic drapes and specialty drapes.
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K Number
K042893Device Name
UNDER BUTTOCKS DRAPE
Manufacturer
INTERNATIONAL MEDSURG CONNECTION, INC.
Date Cleared
2005-03-11
(143 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDSURG CONNECTION, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used as Fluid Collection and by placing under a patient's buttocks in obstetrics procedure (with absorbent pad).
Device Description
The International Medsurg Connection Fluid Collection Under Buttocks Drape.
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K Number
K023808Device Name
IRRIGATION SETS
Manufacturer
INTERNATIONAL MEDSURG CONNECTION
Date Cleared
2003-03-10
(116 days)
Product Code
LJH
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDSURG CONNECTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.
Device Description
The International Medsurg Connections Irrigation Sets.
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