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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The SG 218 Aerosol Tee Adapter is intended for use in a ventilator, oxygen or BIPAP circuit. Dimensions: 22mm O.D. x 18mm I.D./22mm O.D. x 18mm I.D./22mm O.D Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 218
In Commercial Distribution

  • M996SG2182 ()
  • M996SG2180 ()
SG 218

  • Straight/elbow breathing circuit connector, reusable
Reducing Adapter for use in breathing/ventilator circuit. - 30mm I.D. x 22mm O.D. Molded of polysulfone. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 193-M
In Commercial Distribution

  • M996SG193M2 ()
  • M996SG193M0 ()
SG 193-M

  • Straight/elbow breathing circuit connector, reusable
Reducing Adapter for use in breathing/ventilator circuit. - 10mm O.D. x 22mm I.D. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 102
In Commercial Distribution

  • M996SG1022 ()
  • M996SG1020 ()
SG 102

  • Straight/elbow breathing circuit connector, reusable
General Adapter 10mm OD x 10mm OD. Fits components of neonatal ventilator circuits/CPAP systems. Molded of polysulfone. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 1010
In Commercial Distribution

  • M996SG10102 ()
  • M996SG10100 ()
SG 1010

  • Straight/elbow breathing circuit connector, reusable
Reducing Adapter for use in breathing/ventilator circuit. - 15mm O.D. x 22mm I.D. Molded of polysulfone. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 101
In Commercial Distribution

  • M996SG1012 ()
  • M996SG1010 ()
SG 101

  • Straight/elbow breathing circuit connector, reusable
The SG 066-2N-2P 1-liter neoprene reservoir bag is intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. This is a single-use device.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 066-2N-2P
In Commercial Distribution

  • M996SG0662N2P4 ()
  • M996SG0662N2P0 ()
SG 066-2N-2P

  • Breathing circuit bag, single-use
The SG 066-2N 1 liter latex-free reservoir bag is intended to be used with the SG 066 Oxygen Enrichment Kit, while in use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 066-2N
In Commercial Distribution

  • M996SG0662N4 ()
  • M996SG0662N0 ()


  • Breathing circuit bag, single-use
The Instrumentation Industries, Inc. RTC 22-D is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 22-D Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. For use with metered dose inhaler canisters with standard size metal or plastic stems. The RTC 22-D Adapter is intended for Single Patient Reuse. This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 22-D
In Commercial Distribution

  • M996RTC22D5 ()
  • M996RTC22D0 ()
RTC 22-D

  • Metered dose inhaler
The Instrumentation Industries, Inc. RTC 21-D Metered Dose Inhaler Adapter is intended for use in intermittent aerosol therapy to deliver aerosol medications (in compressed canister MDIs) via the proximal end of an endotracheal tube. The RTC 21-D MDI Adapter is intended for single patient use. This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 21-D
In Commercial Distribution

  • M996RTC21D5 ()
  • M996RTC21D0 ()


  • Metered dose inhaler
The Instrumentation Industries, Inc. RTC 15-P is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 15-P Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. For use with metered dose inhaler canisters with standard size metal or plastic stems. The RTC 15-P Adapter is intended for Single Patient Reuse. This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 15-P
In Commercial Distribution

  • M996RTC15P5 ()
  • M996RTC15P0 ()
RTC 15-P

  • Metered dose inhaler
90 degree Elbow Connector - 15mm ID/22mm OD x15mm OD. Molded of polystyrene butadiene. Single patient use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 18901-K
In Commercial Distribution

  • M996KC18901K5 ()
  • M996KC18901K0 ()
KC 18901-K

  • Straight/elbow breathing circuit connector, single-use
Adult Adapter - 15mm ID/22mm OD x15mm ID/22mm OD. Fits components of adult ventilator circuits. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 105
In Commercial Distribution

  • M996KC1052 ()
  • M996KC1050 ()
KC 105

  • Straight/elbow breathing circuit connector, reusable
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 400 fits tubes with 7.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 400
In Commercial Distribution

  • M996JEM4002 ()
  • M996JEM4000 ()

  • Outer Diameter: 6.43 Millimeter
JEM 400

  • Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 370 fits tubes with 7.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 370
In Commercial Distribution

  • M996JEM3702 ()
  • M996JEM3700 ()

  • Outer Diameter: 5.54 Millimeter
JEM 370

  • Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 365 fits tubes with 6.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 365
In Commercial Distribution

  • M996JEM3652 ()
  • M996JEM3650 ()

  • Outer Diameter: 5.54 Millimeter
JEM 365

  • Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 360 fits tubes with 6.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 360
In Commercial Distribution

  • M996JEM3602 ()
  • M996JEM3600 ()

  • Outer Diameter: 5.54 Millimeter
JEM 360

  • Endotracheal tube guide, single-use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 355 fits tubes with 5.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 355
In Commercial Distribution

  • M996JEM3552 ()
  • M996JEM3550 ()

  • Outer Diameter: 4.55 Millimeter
JEM 355

  • Endotracheal tube guide, single-use
This adapter connects to the exhalation valve for additional versatility.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 195-A
In Commercial Distribution

  • M996BE195A0 ()
  • M996BE195A2 ()


  • Non-rebreathing valve, reusable
BE 127-7.5 Wye Connector with (2) 22mm OD ports, (1) 15mm ID/22mm OD port and 7.5mm temperature probe port. Fits components of adult ventilator circuits. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 127-7.5
In Commercial Distribution

  • M996BE127752 ()
  • M996BE127750 ()
BE 127-7.5

  • Y-piece breathing circuit connector, reusable
BE 127 Wye Connector with (2) 22mm OD ports and (1) 15mm ID/22mm OD port. Fits components of adult ventilator circuits. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 127
In Commercial Distribution

  • M996BE1272 ()
  • M996BE1270 ()
BE 127

  • Y-piece breathing circuit connector, reusable
Specialty Adapter - 22mm ID x 22mm OD Adapter for ventilator circuits/CPAP systems. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 120-AKW
In Commercial Distribution

  • M996BE120AKW6 ()
  • M996BE120AKW0 ()
BE 120-AKW

  • Straight/elbow breathing circuit connector, single-use
Specialty Mouthpiece Adapter with 22mm ID fitting. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 120-22D
In Commercial Distribution

  • M996BE12022D6 ()
  • M996BE12022D0 ()
BE 120-22D

  • Breathing mouthpiece, single-use
The BE 117-W Tee Adapter is intended for use in a ventilator, oxygen or BIPAP circuit. Can be used to easily add a monitoring device such as a temperature probe to the breathing circuit. Dimensions: 22mm O.D. x 22mm I.D. x 15mm I.D./22mm O.D. Single Patient Use. Molded of High Density Polyethylene.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 117-W
In Commercial Distribution

  • M996BE117W0 ()
  • M996BE117W2 ()
BE 117-W

  • Straight/elbow breathing circuit connector, single-use
The reusable BE 117 Non-Rebreathing ‘T’ is designed for use with a spontaneously breathing patient where “back flow” must be avoided. The ‘T’ is designed to prevent the flow of gas back toward the source and to ensure unilateral breathing.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 117
In Commercial Distribution

  • M996BE1172 ()
  • M996BE1170 ()


  • Non-rebreathing valve, reusable
BE 105-8 Bronchoscope Swivel - 15mm ID/22mm OD (patient port) x15mm OD (equipment port). Reusable. Fits components of adult ventilator circuits. Molded of polyetherimide. Includes two silicone rubber caps; one cap allows for the use of a suctioning catheter while the other cap allows for the use of a fiber-optic bronchoscope without significant loss of PEEP.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 105-8
In Commercial Distribution

  • M996BE10582 ()
  • M996BE10580 ()
BE 105-8

  • Straight/elbow breathing circuit connector, reusable
BE 105-7 Bronchoscope Swivel - 15mm ID (patient port) x15mm OD (equipment port). Reusable. Fits components of adult ventilator circuits. Molded of polyetherimide. Includes two silicone rubber caps; one cap allows for the use of a suctioning catheter while the other cap allows for the use of a fiber-optic bronchoscope without significant loss of PEEP.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 105-7
In Commercial Distribution

  • M996BE10572 ()
  • M996BE10570 ()
BE 105-7

  • Straight/elbow breathing circuit connector, reusable
Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Single use tourniquet cuffs are intended for single use only. This has dual port capabilities.
Delfi Medical Innovations Inc
9-9800-001
In Commercial Distribution

  • M995998000011 ()
  • M995998000013 ()


  • Tourniquet cuff, single-use
Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Single use tourniquet cuffs are intended for single use only.
Delfi Medical Innovations Inc
9-9700-003
In Commercial Distribution

  • M995997000031 ()
  • M995997000033 ()


  • Tourniquet cuff, single-use
Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Single use tourniquet cuffs are intended for single use only.
Delfi Medical Innovations Inc
9-9700-001
In Commercial Distribution

  • M995997000011 ()
  • M995997000013 ()


  • Tourniquet cuff, single-use
Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Single use tourniquet cuffs are intended for single use only. This part number is specifically used for IVRA (arm) and has dual port capabilities.
Delfi Medical Innovations Inc
9-9400-011
In Commercial Distribution

  • M995994000111 ()
  • M995994000113 ()


  • Tourniquet cuff, single-use
Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Single use tourniquet cuffs are intended for single use only. This part number is specifically used for Lower Leg and has dual port capabilities.
Delfi Medical Innovations Inc
9-9400-004
In Commercial Distribution

  • M995994000041 ()
  • M995994000043 ()


  • Tourniquet cuff, single-use
Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Single use tourniquet cuffs are intended for single use only. This part number is specifically used for Thigh and has dual port capabilities.
Delfi Medical Innovations Inc
9-9400-003
In Commercial Distribution

  • M995994000031 ()
  • M995994000033 ()


  • Tourniquet cuff, single-use
Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Single use tourniquet cuffs are intended for single use only. This part number is specifically used for the Arm and has dual port capabilities.
Delfi Medical Innovations Inc
9-9400-002
In Commercial Distribution

  • M995994000021 ()
  • M995994000023 ()


  • Tourniquet cuff, single-use
Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Single use tourniquet cuffs are intended for single use only. This part number is specifically used for IVRA (arm).
Delfi Medical Innovations Inc
9-9300-011
In Commercial Distribution

  • M995993000111 ()
  • M995993000113 ()


  • Tourniquet cuff, single-use
Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Single use tourniquet cuffs are intended for single use only. This part number is specifically used for the Lower Leg.
Delfi Medical Innovations Inc
9-9300-004
In Commercial Distribution

  • M995993000041 ()
  • M995993000043 ()


  • Tourniquet cuff, single-use
Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Single use tourniquet cuffs are intended for single use only. This part number is specifically used for Arm.
Delfi Medical Innovations Inc
9-9300-002
In Commercial Distribution

  • M995993000021 ()
  • M995993000023 ()


  • Tourniquet cuff, single-use
Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size L
TOP QUALITY MANUFACTURING, INC.
1029
In Commercial Distribution

  • TQ2610292 ()
  • TQ2610291 ()
  • TQ2610290 ()
1029

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size M
TOP QUALITY MANUFACTURING, INC.
1028
In Commercial Distribution

  • TQ2610282 ()
  • TQ2610281 ()
  • TQ2610280 ()
1028

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
A device to disinfect endoscopes
Wassenburg Medical, Inc.
SYSTEM 83 PLUS 9
In Commercial Distribution

  • SYSTEM83PLUS9 ()
  • B21583PLUS9 ()


  • Endoscope washer/disinfector
A device to disinfect endoscopes
Wassenburg Medical, Inc.
SYSTEM 83 PLUS 2
In Commercial Distribution

  • SYSTEM83PLUS2 ()
  • B21583PLUS2 ()


  • Endoscope washer/disinfector
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