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510(k) Data Aggregation
K Number
K972385Device Name
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
Manufacturer
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
Date Cleared
1998-01-20
(208 days)
Product Code
JOH, NOV
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fenestrated Flexible D.I.C. Tracheostomy Tube is indicated for airway management of the tracheostomized patient for providing tracheal access where the use of a fenestration is desirable in order to allow for safe and effective weaning from mechanical ventilation or adjunctive airway support. With the cuff deflated, primary ventilation is allowed to be spontaneous through the fenestrations and around the main tube. This provides a means for phonation when the patient breaths through his/her upper airway. A red decannulation cap can be used to occlude the proximal end of the tracheostomy tube.
Device Description
The Fenestrated Flexible D.I.C. Tracheostomy Tube is made of implant tested, polyvinyl chloride with compatible profile, high volume, low pressure cuff. Radiopaque material is incorporated into the full length of the Fenestrated Flexible D.I.C. Tracheostomy Tube. The cuff inflation line has an inflation indicator and a self sealing luer one-way valve. The tracheostomy tube has three fenestrations on the radius of the tube.
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K Number
K965017Device Name
REGIONAL ANESTHESIA TRAYS
Manufacturer
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
Date Cleared
1997-03-14
(88 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SIMS' Regional Anesthesia Trays are used to administer to a patient regional or local anesthesia.
Device Description
Regional Anesthesia Trays cover a broad product range, including; Continuous Epidural, Single Shot Epidural, Spinal, Nerve Block, Pediatric Epidural, and Combined Spinal/Epidural Trays. These trays are a compilation of the preparatory and surgical components required for administering anesthesia. The trays may include components such as: needles, syringes, filters, catheters, gloves, gauze sponges, drapes, The components are placed into a plastic tray, wrapped in CSR wrap, sealed, and sterilized by ethylene oxide.
The trays are available in standard component configurations or can be customized to meet the needs of an individual user. All componentry supplied in these kits are from an approved list of components which are legally marketed devices.
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K Number
K962175Device Name
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
Manufacturer
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
Date Cleared
1997-01-17
(226 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PORTEX® Adjustable Flange Tracheostomy Tube is indicated for airway management of tracheostomized patients where the ability to adjust the depth of insertion may be advantageous.
Device Description
The PORTEX® Adjustable Flange Tracheostomy Tubes are made of implant tested, polyvinyl chloride with compatible profile, high volume, low pressure cuff. Radiopaque material is incorporated into the full length of the Adjustable Flange Tracheostomy Tube. The trachesstomy tube has an adjustable neck flange and a bonded 15 mm connector. The cuff inflation line has an inflation indicator and a self sealing luer one-way valve.
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K Number
K962931Device Name
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
Manufacturer
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
Date Cleared
1996-10-21
(84 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIMS Pro-Vent® 250 (500) Plus is intended for obtaining small volume samples of blood for the measurement of pH, pO2, pCO2, CO-oximetry, electrolytes (Ca++, Mg++, Na+. Cl-, K+) and the metabolites (Glucose and Lactate).
Device Description
The SIMS Pro-Vent® 250 (500) Plus contains a precision small volume sampling device for obtaining an arterial blood sample. The device consists of a small gauge needle (25g) attached to a single cannula vented tube with a micro volume of 250ul or 500pl (.25 or .50cc). The SIMS Pro-Vent® 250 (500) Plus is ideal for obtaining blood samples from pediatric, neonatal and geriatric patients. Each device contains approximately 40 units of Calcium Neutralized Dry Lithium Heparin per ml. The 250pl device contains approximately 10 U.S.P. units of heparin and the 500ul device contains approximately 20 U.S.P. units of heparin.
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K Number
K963570Device Name
SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
Manufacturer
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
Date Cleared
1996-10-18
(43 days)
Product Code
FMJ
Regulation Number
880.2500Why did this record match?
Applicant Name (Manufacturer) :
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIMS Lumbar Puncture (LP) Kit is indicated for sampling of Cerebrospinal Fluid (CSF) and the measurement of CSF pressure as indicated in standard textbooks.
The SIMS LP Kits are intended to be used when Lumbar Puncture is performed to obtain a CSF specimen for diagnostic study when possible CNS infection is suspected, such as sepsis and/or meningitis. The procedure can also be used to measure intracranial pressure which can result from infection, tumor, hemorthage or edema. This technique is also used to lower intracranial pressure by CSF drainage. CSF pressure is measured prior to CSF sampling using a manometer.
Device Description
The SIMS Lumbar Puncture (LP) Kit is available in adult or pediatric configurations. The kit includes the preparatory and procedural components to perform Lumbar Puncture. A manometer may be included with the kit, depending upon the kit selected.
The SIMS LP Kits with a manometer are used to measure cerebrospinal fluid pressure in centimeters of water (cm of H2O). The manometer consists of two calibrated sections of tubing with a connector welded to the upper portion of the tubing.
Lumbar puncture is performed with standard prep and procedural componentry, similar to those used in spinal anesthesia kits, with the addition of a two part manometer, a 3-way stopcock and 5 inches of small bore extension tubing for the measurement of intracranial CSF pressure.
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K Number
K960429Device Name
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
Manufacturer
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
Date Cleared
1996-05-02
(92 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
The Disposable Inner Cannulae are indicated for use in maintaining airway patency of the outer cannula in the presence of thick tenacious secretions or when it is desirable to minimize the cleaning materials and the nursing time required. The Disposable Inner Cannulae provide a means to protect against the risk of airway obstruction, contamination, and infection.
The Per-Fit™ Percutaneous Tracheostomy Tube is intended for use as a replacement tube for the percutaneous tracheostomy tube that is supplied in the Per-Fit™ Percutaneous Tracheostomy Kit. It is intended to be used for replacement during the initial procedure or as a change-out tube following the procedure.
Device Description
The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral l 5 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.
The Disposable Inner Cannula is made of polyethylene and is ethylene oxide sterilized. The cannula is designated as a single use disposable device for use only with the Portex Percutaneous Tracheostomy Tube.
The Portex® Percutaneous Tracheostomy Tube is designed for insertion via the percutaneous route utilizing the Per-Fit™ Percutaneous Tracheostomy Kit. The tracheostomy tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube features a flexible flange, an integral 15 mm connector, and a cuff that deflates to a low profile for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The tube is supplied with an obturator/dilator sized to match the outer tube and to facilitate insertion.
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