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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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pulse Oximeter, with an optional adapter cable for compatible models.SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the Oximeter. The sensor contains three optical components, (LED) that serves as light sources and one photodiode that acts as light detector. The optical components are housed in adhesive film/rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated by a connector as specified by the different make/ manufacturer of the pulse Oximeter, with an optional adapter cable for compatible models.
MEDIAID INC
CST070-3120
In Commercial Distribution

  • CST07031202 ()
  • B425CST07031202 ()


  • Pulse oximeter, line-powered
SS Height Adjustable Instrument/Straddle Table, 52 inch Leg Clearance. Designed to straddle the OR Table during surgery to keep instruments and equipment directly adjacent to the surgical site. Heavy Duty 16 gauge #304 stainless steel construction. No mixed materials even on the underside of the table to ensure there is no corroding or rusting. Comes with 4 inch casters, 2 swivel, 2 locking. Adjusts in height with stainless steel handle and can be controlled from either end. Handle removes and stores on hook on the inner side of the leg. No open cavities to collect unwanted substances. Height adjusts from 36 inches-56 inches. .
MID CENTRAL MEDICAL CORP.
MCM535
In Commercial Distribution

  • 10810030862946 ()

  • Width: 24 Inch
  • Length: 60 Inch
  • Height: 52 Inch
MCM535

  • Operating table accessory trolley
SS Height Adjustable Instrument/Straddle Table, 40 inch Leg Clearance. Designed to straddle the OR Table during surgery to keep instruments and equipment directly adjacent to the surgical site. Heavy Duty 16 gauge #304 stainless steel construction. No mixed materials even on the underside of the table to ensure there is no corroding or rusting. Comes with 4 inch casters, 2 swivel, 2 locking. Adjusts in height with stainless steel handle and can be controlled from either end. Handle removes and stores on hook on the inner side of the leg. No open cavities to collect unwanted substances. Height adjusts from 36 inch-56 inch. . .
MID CENTRAL MEDICAL CORP.
MCM532
In Commercial Distribution

  • 10810030862922 ()

  • Width: 24 Inch
  • Length: 48 Inch
  • Height: 40 Inch
MCM532

  • Operating table accessory trolley
SS Height Adjustable Instrument/Straddle Table, 28 inch Leg Clearance. Designed to straddle the OR Table during surgery to keep instruments and equipment directly adjacent to the surgical site. Heavy Duty 16 gauge #304 stainless steel construction. No mixed materials even on the underside of the table to ensure there is no corroding or rusting. Comes with 4 inch casters, 2 swivel, 2 locking. Adjusts in height with stainless steel handle and can be controlled from either end. Handle removes and stores on hook on the inner side of the leg. No open cavities to collect unwanted substances. Height adjusts from 36 inches - 56 inches. . .
MID CENTRAL MEDICAL CORP.
MCM531
In Commercial Distribution

  • 10810030862915 ()

  • Width: 24 Inch
  • Length: 36 Inch
  • Height: 28 Inch
MCM531

  • Operating table accessory trolley
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The rear foot plates include lapidus plates, interpositioning plates, universal rear foot plates, rear foot reconstruction plates, flat line arthrodesis plates, dwyer displacement plates, calcaneus plates, and fibular plates. Also included are 3.7mm locking screws.
Ascension Orthopedics, Inc.
RFOOTIMP
Not in Commercial Distribution

  • M268RFOOTIMP1 ()
  • 10381780064640 ()
RFOOTIMP

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
SS Height Adjustable Instrument/Straddle Table, 26 inch Leg Clearance. Designed to straddle the OR Table during surgery to keep instruments and equipment directly adjacent to the surgical site. Heavy Duty 16 gauge #304 stainless steel construction. No mixed materials even on the underside of the table to ensure there is no corroding or rusting. Comes with 4 inch casters, 2 swivel, 2 locking. Adjusts in height with stainless steel handle and can be controlled from either end. Handle removes and stores on hook on the inner side of the leg. No open cavities to collect unwanted substances. Height adjusts from 36 inches - 56 inches. . .
MID CENTRAL MEDICAL CORP.
MCM533
In Commercial Distribution

  • 10810030862939 ()

  • Width: 46 Inch
  • Length: 34 Inch
  • Height: 26 Inch
MCM533

  • Operating table accessory trolley
AIR SUPPLY Air supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. MRI SAFETY PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Safety strap buckles are constructed from Polypropylene. Air supply fasteners are manufactured from non-ferrous metal. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI. CLEANING Disposable Models The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3703
In Commercial Distribution

  • 10818566019193 ()
  • 00818566019196 ()

  • Length: 50 Inch
3703

  • Patient transfer system, powered
AIR SUPPLY Air supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. MRI SAFETY PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Safety strap buckles are constructed from Polypropylene. Air supply fasteners are manufactured from non-ferrous metal. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI. CLEANING Disposable Models The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3702
In Commercial Distribution

  • 00818566019189 ()
  • 10818566019186 ()

  • Length: 39 Inch


  • Patient transfer system, powered
The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0022
In Commercial Distribution

  • EABA40000221 ()
  • EABA40000220 ()
400-0022

  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
The Procleix Xpress System v3.2 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.2
In Commercial Distribution

  • 00866489000098 ()
741743

  • Nucleic acid sample preparation instrument IVD, semi-automated
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