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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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SH 75-BL Barbed Tubing Adapter - M996SH75BL0

The SH 75-BL Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 75-BL - Blue
In Commercial Distribution

  • M996SH75BL5 ()
  • M996SH75BL0 ()
  • M996SH75BL4 ()
SH 75-BL

  • Oxygen administration kit

SH 74-Y Barbed Tubing Adapter - M996SH74Y0

The SH 74-Y Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 74-Y - Yellow
In Commercial Distribution

  • M996SH74Y5 ()
  • M996SH74Y0 ()
  • M996SH74Y4 ()
SH 74-Y

  • Oxygen administration kit

SH 74-G Barbed Tubing Adapter - M996SH74G0

The SH 74-G Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 74-G - Green
In Commercial Distribution

  • M996SH74G5 ()
  • M996SH74G0 ()
  • M996SH74G4 ()
SH 74-G

  • Oxygen administration kit

SH 74-BL Barbed Tubing Adapter - M996SH74BL0

The SH 74-BL Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 74-BL - Blue
In Commercial Distribution

  • M996SH74BL5 ()
  • M996SH74BL0 ()
  • M996SH74BL4 ()
SH 74-BK

  • Oxygen administration kit

SH 7-47 Nose Clip - M996SH7470

SH 7-47 Nose Clip holds patient's nostrils closed during testing and treatment. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 7-47
In Commercial Distribution

  • M996SH7476 ()
  • M996SH7470 ()
  • M996SH7475 ()
SH 7-47

  • Nose clip, single-use

SG 101-D Reducing Adapter - M996SG101D0

Reducing Adapter for use in breathing/ventilator circuit. 15mm ID x 22mm ID. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 101-D
In Commercial Distribution

  • M996SG101D6 ()
  • M996SG101D0 ()
  • M996SG101D4 ()
SG 101-D

  • Straight/elbow breathing circuit connector, single-use

RTC 24-VP Universal Metered Dose Inhaler Adapter - M996RTC24VP0

The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-VP MDI Adapter 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-VP MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-VP MDI 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 24-VP
In Commercial Distribution

  • M996RTC24VP4 ()
  • M996RTC24VP0 ()
  • M996RTC24VP5 ()


  • Metered dose inhaler

PF 1515 Straight Silicone Rubber Connector - M996PF15150

Straight Connector - 15mm ID x 15mm ID. Fits components of pediatric ventilator circuits. Molded of silicone rubber. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
PF 1515
In Commercial Distribution

  • M996PF15152 ()
  • M996PF15150 ()
  • M996PF15155 ()
PF 1515

  • Straight/elbow breathing circuit connector, reusable

PF 1010 Straight Silicone Rubber Connector - M996PF10100

Straight Connector - 10mm ID x 10mm ID. Fits components of neonatal ventilator circuits. Molded of silicone rubber. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
PF 1010
In Commercial Distribution

  • M996PF10102 ()
  • M996PF10100 ()
  • M996PF10105 ()
PF 1010

  • Straight/elbow breathing circuit connector, reusable

NP 105-1 Safety Strap - M996NP10510

Ventilator Tubing Accessory - Safety Strap helps to prevent disconnects by securing ventilator circuit components.
INSTRUMENTATION INDUSTRIES, INCORPORATED
NP 105-1
In Commercial Distribution

  • M996NP10510 ()
  • M996NP10512 ()
  • M996NP10515 ()
NP 105-1

  • Ventilator breathing circuit, single-use

KC 213-D 60 degree Angle Wye Connector - M996KC213D0

KC 213-D Wye connector with (3) 22mm OD ports. Fits components of adult ventilator circuits. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 213-D
In Commercial Distribution

  • M996KC213D6 ()
  • M996KC213D0 ()
  • M996KC213D5 ()
KC 213-D

  • Y-piece breathing circuit connector, single-use

KC 212-D 90 degree Angle Wye Connector - M996KC212D0

KC 212-D Wye connector with one - 18mm ID/22mm OD nebulizer port x (3) 22mm OD ports. Fits components of adult ventilator circuits. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 212-D
In Commercial Distribution

  • M996KC212D6 ()
  • M996KC212D0 ()
  • M996KC212D5 ()
KC 212-D

  • Y-piece breathing circuit connector, single-use

KC 2126 Reducing Adapter - M996KC21260

Reducing adapter for use in breathing/ventilator circuit. 22mm ID x 22mm OD. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 2126
In Commercial Distribution

  • M996KC21266 ()
  • M996KC21260 ()
  • M996KC21264 ()
KC 2126

  • Straight/elbow breathing circuit connector, single-use

KC 2124 Adapter - M996KC21240

General Adapter - 15mm ID/22mm OD x 15mm ID/22mm OD. Fits components of adult ventilator circuits/CPAP systems. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 2124
In Commercial Distribution

  • M996KC21246 ()
  • M996KC21240 ()
  • M996KC21244 ()
KC 2124

  • Straight/elbow breathing circuit connector, single-use

KC 211-D 60 degree Angle Wye Connector - M996KC211D0

KC 211-D Wye connector with one - 18mm ID/22mm OD nebulizer port x (3) 22mm OD ports. Fits components of adult ventilator circuits. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 211-D
In Commercial Distribution

  • M996KC211D6 ()
  • M996KC211D0 ()
  • M996KC211D5 ()
KC 211-D

  • Y-piece breathing circuit connector, single-use

KC 18901-P Elbow Connector - M996KC18901P0

90 degree Elbow Connector - 15mm ID/22mm OD x15mm OD. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 18901-P
In Commercial Distribution

  • M996KC18901P2 ()
  • M996KC18901P0 ()
  • M996KC18901P3 ()
KC 18901-P

  • Straight/elbow breathing circuit connector, reusable

KC 18901-L Elbow Connector - M996KC18901L0

90 degree Elbow Connector with Luer Lock Port - 15mm ID/22mm OD x15mm OD. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 18901-L
In Commercial Distribution

  • M996KC18901L2 ()
  • M996KC18901L0 ()
  • M996KC18901L3 ()
KC 18901-L

  • Straight/elbow breathing circuit connector, reusable

KC 1515 Adapter - M996KC15150

General Adapter 15mm OD x 15mm OD. Fits components of pediatric ventilator circuits/CPAP systems. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 1515
In Commercial Distribution

  • M996KC15156 ()
  • M996KC15150 ()
  • M996KC15154 ()
KC 1515

  • Straight/elbow breathing circuit connector, single-use

KC 145-1522D Hose Connector - M996KC1451522D0

The KC 145-1522D Hose Connector: Dimensions - 15mm I.D/22mm O.D. x tapered barb adapter
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 145-1522D
In Commercial Distribution

  • M996KC1451522D6 ()
  • M996KC1451522D0 ()
  • M996KC1451522D4 ()
KC 145-1522D

  • Anaesthesia breathing circuit, single-use

KC 1010 Adapter - M996KC10100

General Adapter 10mm OD x 10mm OD. Fits components of neonatal ventilator circuits/CPAP systems. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 1010
In Commercial Distribution

  • M996KC10106 ()
  • M996KC10100 ()
  • M996KC10104 ()
KC 1010

  • Straight/elbow breathing circuit connector, single-use

DS 7-45 Bronchoscope Swivel - M996DS7450

DS 7-45 Bronchoscope Swivel - 15mm ID/22mm OD (patient port) x 15mm OD (equipment port). Fits components of adult ventilator circuits. Includes one thermoplastic rubber cap; cap allows for the use of a suctioning catheter or fiber-optic bronchoscope without significant loss of PEEP. Single-Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
DS 7-45
In Commercial Distribution

  • M996DS7454 ()
  • M996DS7450 ()
  • M996DS7455 ()
DS 7-45

  • Straight/elbow breathing circuit connector, single-use

Pilot Tube Repair Kit - M996BE4090

Pilot tube repair kit is used to repair a leaking pilot line of endotracheal and tracheostomy tubes with inside diameters of 0.032 inch (21 gauge) to 0.050 inch (18 gauge). Use of a pilot tube repair kit can delay the replacement of the endotracheal or tracheostomy tube thus reducing trauma to the patient.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 409
In Commercial Distribution

  • M996BE4090 ()
  • M996BE4092 ()
  • M996BE4091 ()
BE 409

  • Tracheal pilot tube repair kit

BE 145-2P Hose Connector - M996BE1452P0

The BE 145-2P Hose Connector: Dimensions - 15mm O.D. x tapered barb adapter
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 145-2P
In Commercial Distribution

  • M996BE1452P0 ()
  • M996BE1452P2 ()
  • M996BE1452P5 ()
BE 145-2P

  • Low-pressure tubing connector, reusable

BE 145-2230P Hose Connector - M996BE1452230P0

The BE 145-2230P Hose Connector: Dimensions - 22mm I.D/30mm O.D. x tapered barb adapter
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 145-2230P
In Commercial Distribution

  • M996BE1452230P5 ()
  • M996BE1452230P0 ()
  • M996BE1452230P2 ()
BE 145-2230P

  • Low-pressure tubing connector, reusable

BE 105-2X22 Adapter - M996BE1052X220

General Adapter - 22mm ID x 22mm ID adapter for use in breathing/ventilator circuit. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 105-2X22
In Commercial Distribution

  • M996BE1052X224 ()
  • M996BE1052X220 ()
  • M996BE1052X221 ()
BE 105-2X22

  • Straight/elbow breathing circuit connector, reusable

BE 101-00-3443 Straight Connector - M996BE1010034430

Straight Connector - 22mm ID x 22mm ID. Fits components of adult ventilator circuits. Molded of silicone rubber. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 101-00-3443
In Commercial Distribution

  • M996BE1010034435 ()
  • M996BE1010034430 ()
  • M996BE1010034432 ()
BE 101-00-3443

  • Straight/elbow breathing circuit connector, reusable

ADP 150 Hose Connector - M996ADP1500

The ADP 150 Hose Connector: Dimensions - 15mm O.D. x 1/2" O/D. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
ADP 150
In Commercial Distribution

  • M996ADP1505 ()
  • M996ADP1500 ()
  • M996ADP1502 ()
ADP 150

  • Low-pressure tubing connector, reusable

Matching Limb Protection Sleeves - Easi-Fit BFR - M995979500241

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. 24" MLPS.
Delfi Medical Innovations Inc
9-7950-024
In Commercial Distribution

  • M995979500241 ()
  • M995979501243 ()
  • M995979500243 ()


  • Stockinette

Coeur Nemoto - M902550500

50mL Disposable Syringe
COEUR, INC.
C855-5050
In Commercial Distribution

  • M902550506 ()
  • M902550505 ()
  • M902550500 ()

  • Total Volume: 50 Milliliter
C855-5050

  • Angiographic syringe

Coeur/Nemoto - M902124200

1200 PSI High Pressure Y-Line with Rotating Adapter
COEUR, INC.
C453-2420
In Commercial Distribution

  • M902124206 ()
  • M902124205 ()
  • M902124200 ()
C453-2420

  • Radiographic procedure tubing

Coeur Nemoto - M902121510

60” (1500mm) 300psi Extension Y-Line with Check Valve
COEUR, INC.
C455-2151
In Commercial Distribution

  • M902121516 ()
  • M902121515 ()
  • M902121510 ()

  • Length: 60 Inch
C455-2151

  • Radiographic procedure tubing

Coeur Nemoto - M902115000

60” (1500mm) 330psi Extension Line
COEUR, INC.
C455-1500
In Commercial Distribution

  • M902115006 ()
  • M902115005 ()
  • M902115000 ()

  • Length: 60 Inch
C455-1500

  • Radiographic procedure tubing

Coeur Nemoto - M902109040

8” Fill Tube
COEUR, INC.
C455-0904
In Commercial Distribution

  • M902109046 ()
  • M902109045 ()
  • M902109040 ()

  • Length: 8 Inch
C455-0904

  • Radiographic procedure tubing

Coeur Nemoto - M902100600

60” (1500mm) 330psi Coiled Connector Tube
COEUR, INC.
C455-0060
In Commercial Distribution

  • M902100606 ()
  • M902100605 ()
  • M902100600 ()

  • Length: 60 Inch
C455-0060

  • Radiographic procedure tubing

QuickProfile™ 2019-nCoV IgG/IgM Antibody Test - M90171108B0

QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
LUMIQUICK DIAGNOSTICS, INC.
71108B
In Commercial Distribution

  • M90171108B1 ()
  • M90171108B0 ()
  • M90171108B2 ()

  • Length: 80 Millimeter
71108B

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

SurgiLux™ - M710SL120

No Description
BIOTEX, INC.
SL-12
In Commercial Distribution

  • M710SL122 ()
  • M710SL120 ()
  • M710SL124 ()
SL-12

  • Operating room light

ENSIZOR - M707ES26235

The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 235 cm.
SLATER ENDOSCOPY LLC
ES26235
In Commercial Distribution

  • M707ES26235 ()
  • M707ES262351 ()
  • M707ES262350 ()

  • Length: 235 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26235

  • Flexible endoscopic scissors, single-use

ENSIZOR - M707ES26165

The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 165 cm.
SLATER ENDOSCOPY LLC
ES26165
In Commercial Distribution

  • M707ES26165 ()
  • M707ES261651 ()
  • M707ES261650 ()

  • Length: 165 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26165

  • Flexible endoscopic scissors, single-use

Stradis Medical, LLC - M752TMSCP1ML0

SYRINGE CONVENIENCE PACK-1CC L/L
STRADIS MEDICAL LLC
TM.SCP1ML
In Commercial Distribution

  • M752TMSCP1ML5 ()
  • M752TMSCP1ML0 ()
  • M752TMSCP1ML1 ()


  • General-purpose syringe, single-use

Stradis Medical, LLC - M752TMFFTK0

FLUID FILTER TRANSFER KIT
STRADIS MEDICAL LLC
TM.FFTK
In Commercial Distribution

  • M752TMFFTK5 ()
  • M752TMFFTK0 ()
  • M752TMFFTK1 ()


  • Fluid transfer set, general-purpose
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