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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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SG 101 Reducing Adapter - M996SG1010

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

SG 066-2N-2P 1 liter reservoir bag - M996SG0662N2P0

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

SG 066-2N 1 liter latex-free reservoir bag - M996SG0662N0

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

RTC 24-V Universal Metered Dose Inhaler Adapter Kit - M996RTC24VKIT0

The Instrumentation Industries, Inc. RTC 24-V KIT includes the RTC 24-V MDI Adapter actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V KIT is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V KIT is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V KIT is Critical Care and/or long term or short term ventilation. The components of the RTC 24-V KIT consist of one RTC 24-V MDI Adapter, one four inch length of 22mm inner-diameter tubing, and one 15mm inner-diameter/22mm outer-diameter adapter. The RTC 24-V KIT is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 24-V Kit
In Commercial Distribution

  • M996RTC24VKIT0 ()
  • M996RTC24VKIT2 ()


  • Metered dose inhaler

RTC 23-D Metered Dose Inhaler Adapter - M996RTC23D0

The Instrumentation Industries, Inc. RTC 23-D is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 23-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 23-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 23-D
In Commercial Distribution

  • M996RTC23D5 ()
  • M996RTC23D0 ()
RTC 23-D

  • Metered dose inhaler

RTC 15-P Metered Dose Inhaler Adapter - M996RTC15P0

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

RTC 15-D Metered Dose Inhaler Adapter - M996RTC15D0

The Instrumentation Industries, Inc. RTC 15-D is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 15-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 15-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 15-D
In Commercial Distribution

  • M996RTC15D0 ()
  • M996RTC15D5 ()
RTC 15-D

  • Metered dose inhaler

PS 54-1A Adapter for Exhalation Valves - M996PS541A0

This adapter connects to the exhalation valve for additional versatility.
INSTRUMENTATION INDUSTRIES, INCORPORATED
PS 54-1A
In Commercial Distribution

  • M996PS541A0 ()
  • M996PS541A2 ()


  • Non-rebreathing valve, reusable

NP 1000-2D O2 Instant Flow Valve Bag Hanger - M996NP10002D0

NP 1000-2D Bag Hanger mates with arm of O2 Instant Flow Valve to support a resuscitation bag. This is an accessory to the BE 3000 Series Oxygen Instant Flow Valves. Single Patient Use
INSTRUMENTATION INDUSTRIES, INCORPORATED
NP 1000-2D
In Commercial Distribution

  • M996NP10002D5 ()
  • M996NP10002D0 ()
NP 1000-2D

  • Respiratory oxygen therapy system

NL 100 Breast Marker - M996NL1000

NL 100 Breast Marker is used to assist in nipple placement during breast reconstructive surgery. A temporary impression is made by pressing the marker onto skin with a gentle rotating motion. Methylene blue may be used as a marking agent. The NL 100 Breast Marker provides two marking edges: 42 mm and 38 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
NL 100
In Commercial Distribution

  • M996NL1004 ()
  • M996NL1000 ()
NL 100

  • Skin marking guide, single-use

KM 030 Disposable Connector with LCD Thermometer - M996KM0300

The KM 030 Disposable Connector with LCD Thermometer is intended for use in a ventilator circuit, or a heated aerosol circuit. The LCD thermometer gives approximate temperature readings only and is not a substitute for definitive temperature monitoring. Dimensions: 22mm O.D. x 22mm I.D. Single Patient Use. Molded of High Density Polyethylene.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KM 030
In Commercial Distribution

  • M996KM0305 ()
  • M996KM0300 ()
KM 030

  • Straight/elbow breathing circuit connector, single-use

KC 9-P Auto-PEEP Measurement Device - M996KC9P0

The KC 9-P with removable cap is designed for use on ventilators not equipped with expiratory hold. It allows single breath measurement of auto-PEEP in its use as a Braschi valve. Objectives of PEEP therapy: 1) increase functional residual capacity by maintaining a positive pressure throughout the ventilatory cycle - improves gas distribution, 2) aid in the prevention of atelectasis via aveolar stinting, 3) decrease in the inspired oxygen fraction (FiO2) is an advantage, 4) help in the stabilization of flail chest condition, and 5) monitor tidal volume by connecting a spirometer to the outlet port.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 9-P
In Commercial Distribution

  • M996KC9P0 ()
  • M996KC9P2 ()


  • Non-rebreathing valve, single-use

KC 18901-K Elbow Connector - M996KC18901K0

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

JEM 370 Endotracheal Tube Changer - M996JEM3700

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

BE 195-A Adapter for Exhalation Valves - M996BE195A0

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 195-1522A Reducing Adapter - M996BE1951522A0

Reducing Adapter for use in breathing/ventilator circuit. - 15mm I.D./22mm O.D. x 30mm I.D. Molded of polyetherimide. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 195-1522A
In Commercial Distribution

  • M996BE1522A2 ()
  • M996BE1951522A0 ()
BE 195-1522A

  • Straight/elbow breathing circuit connector, reusable

BE 193 Reducing Adapter - M996BE1930

Reducing Adapter for use in breathing/ventilator circuit. - 22mm O.D. x 30mm I.D. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 193
In Commercial Distribution

  • M996BE1932 ()
  • M996BE1930 ()
BE 193

  • Straight/elbow breathing circuit connector, reusable

BE 192 Reducing Adapter - M996BE1920

Reducing Adapter for use in breathing/ventilator circuit. - 22mm I.D. x 30mm O.D. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 192
In Commercial Distribution

  • M996BE1922 ()
  • M996BE1920 ()
BE 192

  • Straight/elbow breathing circuit connector, reusable

BE 191 Reducing Adapter - M996BE1910

Reducing Adapter for use in breathing/ventilator circuit. - 22mm I.D. x 30mm I.D. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 191
In Commercial Distribution

  • M996BE1912 ()
  • M996BE1910 ()
BE 191

  • Straight/elbow breathing circuit connector, reusable

BE 190 Reducing Adapter - M996BE1900

Reducing Adapter for use in breathing/ventilator circuit. - 22mm O.D. x 30mm O.D. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 190
In Commercial Distribution

  • M996BE1902 ()
  • M996BE1900 ()
BE 190

  • Straight/elbow breathing circuit connector, reusable

BE 150-5LF Test Lung - M996BE1505LF0

BE 150-5LF Test Lung has a 22mm I.D. connection and a 750 ml capacity; Not made with natural rubber latex. Not for patient use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 150-5LF
In Commercial Distribution

  • M996BE1505LF0 ()
  • M996BE1505LF1 ()
BE 150-5LF

  • Lung physical simulator

BE 150-5G Test Lung - M996BE1505G0

BE 150-5G Test Lung has a 22mm I.D. connection and a 1 liter capacity; Not made with natural rubber latex. Not for patient use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 150-5G
In Commercial Distribution

  • M996BE1505G0 ()
  • M996BE1505G1 ()
BE 150-5G

  • Lung physical simulator

BE 139-105 Reducing Adapter - M996BE1391050

Reducing Adapter for use in breathing/ventilator circuit. - 15mm O.D. x 15mm I.D./22mm O.D. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 139-105
In Commercial Distribution

  • M996BE1391052 ()
  • M996BE1391050 ()
BE 139-105

  • Straight/elbow breathing circuit connector, reusable

BE 131 One-Way Valve - M996BE1310

The reusable BE 131 One-Way Valve is designed for use in any breathing circuit or ventilatory system where "back flow" must be avoided. It is designed to prevent the flow of gas back toward the source. The device includes a silicone rubber connector with 22mm I.D. Inlet.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 131
In Commercial Distribution

  • M996BE1312 ()
  • M996BE1310 ()


  • Non-rebreathing valve, reusable

Matching Limb Protection Sleeves - Easi-Fit - M995979200341

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff.
Delfi Medical Innovations Inc
9-7920-034
In Commercial Distribution

  • M995979200341 ()
  • M995979200343 ()


  • Stockinette

Matching Limb Protection Sleeves - Easi-Fit - M995979200241

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff.
Delfi Medical Innovations Inc
9-7920-024
In Commercial Distribution

  • M995979200241 ()
  • M995979200243 ()


  • Stockinette

Matching Limb Protection Sleeves - Easi-Fit - M995979200181

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff.
Delfi Medical Innovations Inc
9-7920-018
In Commercial Distribution

  • M995979200181 ()
  • M995979200183 ()


  • Stockinette

Matching Limb Protection Sleeves - Vari-Fit - M995979200031

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff. This sleeve is specifically for thigh.
Delfi Medical Innovations Inc
9-7920-003
In Commercial Distribution

  • M995979200031 ()
  • M995979200033 ()


  • Stockinette

Matching Limb Protection Sleeves - Vari-Fit - M995979200021

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff. This sleeve is specifically for arms.
Delfi Medical Innovations Inc
9-7920-002
In Commercial Distribution

  • M995979200021 ()
  • M995979200023 ()


  • Stockinette

Matching Limb Protection Sleeves - Vari-Fit - M995979200011

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff. This sleeve is specifically for Lower Leg.
Delfi Medical Innovations Inc
9-7920-001
In Commercial Distribution

  • M995979200011 ()
  • M995979200013 ()


  • Stockinette

Matching Limb Protection Sleeves - Petite-Fit - M995979100021

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff.
Delfi Medical Innovations Inc
9-7910-002
In Commercial Distribution

  • M995979100021 ()
  • M995979100023 ()


  • Stockinette

Matching Limb Protection Sleeves - Petite-Fit - M995979100011

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff.
Delfi Medical Innovations Inc
9-7910-001
In Commercial Distribution

  • M995979100011 ()
  • M995979100013 ()


  • Stockinette

Matching Limb Protection Sleeves - Pedi-Fit - M995979000041

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff.
Delfi Medical Innovations Inc
9-7900-004
In Commercial Distribution

  • M995979000041 ()
  • M995979000043 ()


  • Stockinette

Matching Limb Protection Sleeves - Pedi-Fit - M995979000031

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff.
Delfi Medical Innovations Inc
9-7900-003
In Commercial Distribution

  • M995979000031 ()
  • M995979000033 ()


  • Stockinette

Matching Limb Protection Sleeves - Pedi-Fit - M995979000021

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff.
Delfi Medical Innovations Inc
9-7900-002
In Commercial Distribution

  • M995979000021 ()
  • M995979000023 ()


  • Stockinette

Matching Limb Protection Sleeves - Pedi-Fit - M995979000011

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi MLPS is intended for use with a specific Delfi tourniquet cuff.
Delfi Medical Innovations Inc
9-7900-001
In Commercial Distribution

  • M995979000011 ()
  • M995979000013 ()


  • Stockinette

Pedi-Fit Sterile Single Use - M995609800004001

Delfi single use tourniquet cuffs are available in various models for pediatric and adult patients. Available in a selection of lengths and widths to facilitate a proper fit, and color coded for size identification. Single use tourniquet cuffs are intended for single use only. This cuff is P3.5 inches and has dual port capabilities.
Delfi Medical Innovations Inc
60-9800-004-00
In Commercial Distribution

  • M995609800004001 ()
  • M995609800004003 ()


  • Tourniquet cuff, single-use

Pedi-Fit Sterile Single Use - M995609800003001

Delfi single use tourniquet cuffs are available in various models for pediatric and adult patients. Available in a selection of lengths and widths to facilitate a proper fit, and color coded for size identification. Single use tourniquet cuffs are intended for single use only. This cuff is P3.0 inches and has dual port capabilities.
Delfi Medical Innovations Inc
60-9800-003-00
In Commercial Distribution

  • M995609800003001 ()
  • M995609800003003 ()


  • Tourniquet cuff, single-use

Pedi-Fit Sterile Single Use - M995609800002001

Delfi single use tourniquet cuffs are available in various models for pediatric and adult patients. Available in a selection of lengths and widths to facilitate a proper fit, and color coded for size identification. Single use tourniquet cuffs are intended for single use only. This cuff is P2.25 inches and has dual port capabilities.
Delfi Medical Innovations Inc
60-9800-002-00
In Commercial Distribution

  • M995609800002001 ()
  • M995609800002003 ()


  • Tourniquet cuff, single-use

Pedi-Fit Sterile Single Use - M995609800001001

Delfi single use tourniquet cuffs are available in various models for pediatric and adult patients. Available in a selection of lengths and widths to facilitate a proper fit, and color coded for size identification. Single use tourniquet cuffs are intended for single use only. This cuff is P1.5 inches and has dual port capabilities.
Delfi Medical Innovations Inc
60-9800-001-00
In Commercial Distribution

  • M995609800001001 ()
  • M995609800001003 ()


  • Tourniquet cuff, single-use
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