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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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BE 105-2222 Swivel Adapter - M996BE1052220

Swivel Adapter 22mm ID x 15mm ID/22mm OD. Specialty adapter for ventilator circuits/CPAP systems. Swivels 360 degrees. Molded of polypropylene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 105-2222
In Commercial Distribution

  • M996BE10522226 ()
  • M996BE1052220 ()
  • M996BE10522222 ()
BE 105-2222

  • Straight/elbow breathing circuit connector, single-use

AM 100P Anesthesia Flush Plug - M996AM100P0

A device with a handle used to plug the end of an anesthesia circuit/breathing circuit at two possible locations: the Y-piece or the gas sampling elbow. The temporary plugging of the anesthesia breathing circuit allows anesthetic gases to be flushed from the anesthesia machine through the WAG (waste anesthetic gas) scavenging line by way of continuous oxygen/air flow rate over a set amount of time, or by activating the flush valve and applying positive bag pressure in repeated succession. This practice reduces the amount of anesthetic gas released into the operating room and thus reduces harmful gas exposure to operating room personnel and premature anesthetic gas exposure to patients during preoxygenation or mask induction. There is no patient contact as the plug must be removed before the breathing circuit can be attached to a mask, endo/naso-tracheal tube, or any other breathing device.
INSTRUMENTATION INDUSTRIES, INCORPORATED
AM 100P
In Commercial Distribution

  • M996AM100P5 ()
  • M996AM100P0 ()
  • M996AM100P4 ()
AM 100P

  • Breathing circuit pressure detection port plug

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 - M995979500341

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. 34" MLPS.
Delfi Medical Innovations Inc
9-7950-034
In Commercial Distribution

  • M995979500341 ()
  • M995979501343 ()
  • M995979500343 ()


  • Stockinette

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

Matching Limb Protection Sleeves - Easi-Fit BFR - M995979500181

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. 18" MLPS.
Delfi Medical Innovations Inc
9-7950-018
In Commercial Distribution

  • M995979500181 ()
  • M995979501183 ()
  • M995979500183 ()


  • Stockinette

Lucitone® HIPA - D0019059540

Original Opaque
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059561 ()
  • D0019059540 ()
  • D0019060222 ()

  • Weight: 1000 Gram
905954

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059330

Light
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060192 ()
  • D0019059431 ()
  • D0019059330 ()

  • Weight: 1000 Gram
905933

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059350

Dark Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060212 ()
  • D0019059451 ()
  • D0019059350 ()

  • Weight: 1000 Gram
905935

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059340

Light Reddish Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059441 ()
  • D0019059340 ()
  • D0019060202 ()

  • Weight: 1000 Gram
905934

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059320

Original
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059421 ()
  • D0019059320 ()
  • D0019060182 ()

  • Weight: 1000 Gram
905932

  • Dental appliance fabrication material, resin

Quala - D023GCPKA1

Quala Mask Surgical Molded Pink
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCPKA
In Commercial Distribution

  • D023GCPKA5 ()
  • D023GCPKA3 ()
  • D023GCPKA1 ()
GCPKA

  • Surgical/medical respirator, non-antimicrobial, single-use

Quala - D023GCIPKA1

Quala Mask Earloop Latex Free Pink
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCIPKA
In Commercial Distribution

  • D023GCIPKA5 ()
  • D023GCIPKA3 ()
  • D023GCIPKA1 ()
GCIPKA

  • Surgical/medical respirator, non-antimicrobial, single-use

Quala - D023GCILVA1

Quala Mask Earloop Latex Free Lavender
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCILVA
In Commercial Distribution

  • D023GCILVA50 ()
  • D023GCILVA3 ()
  • D023GCILVA1 ()
GCILVA

  • Surgical/medical respirator, non-antimicrobial, single-use

Quala - D023GCIBLA1

Quala Mask Earloop Latex Free Blue
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCIBLA
In Commercial Distribution

  • D023GCIBLA5 ()
  • D023GCIBLA3 ()
  • D023GCIBLA1 ()
GCIBLA

  • Surgical/medical respirator, non-antimicrobial, single-use

Quala - D023GCBLA13

Quala Mask Surgical Molded Blue
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCBLA
In Commercial Distribution

  • D023GCBLA55 ()
  • D023GCBLA33 ()
  • D023GCBLA13 ()
GCBLA

  • Surgical/medical respirator, non-antimicrobial, single-use

BiWaze Clear System - B965BK181

The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The BiWaze Clear System may be used with a patient interface like face mask, mouthpiece, a trach adapter to a patient’s endotracheal or tracheostomy tube. It is for use on adult or paediatric patients in acute, post-acute, and home care environments. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting
Abmrc LLC
BK181
In Commercial Distribution

  • B965BK367 ()
  • B965BK181 ()
  • B965BK368 ()
BK181

  • In-exsufflation/lung-oscillation airway secretion-clearing system

Sample Line with Nafion Tube Kit - B882900310

The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH.
Beyond Air, Inc.
90031
In Commercial Distribution

  • B882900310 ()
  • B882900311 ()
  • B882900312 ()


  • Nitric oxide delivery system, secondary

22mm Gas Sample Adaptor Kit - B882900170

90017 is a kit containing two off-the-shelf components: - 1: (61928) 22M-22F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 22mm-diameter breathing circuit.
Beyond Air, Inc.
90017
In Commercial Distribution

  • B882900171 ()
  • B882900170 ()
  • B882900172 ()


  • Nitric oxide delivery system, secondary

Luer Elbow 7.6mm Port Kit - B882900160

The Luer elbow is a component to the gas sampling port which fits on a breathing circuit.
Beyond Air, Inc.
90016
In Commercial Distribution

  • B882900161 ()
  • B882900160 ()
  • B882900162 ()


  • Nitric oxide delivery system, secondary

LungFit PH Verification Kit - B882900150

The LungFit PH Verification Kit (p/n 90015) is used during the Verification Check procedure to check the performance of the system before the system is attached to the patient circuit. The NDM is attached between the two open lengths of 22mm tubing and the gas sample line is attached to the sample T adaptor. A full description of how it is used is included in the LungFit PH Operators Manual section 9.3 (Beyond Air p/n 20038).
Beyond Air, Inc.
90015
In Commercial Distribution

  • B882900151 ()
  • B882900150 ()
  • B882900152 ()


  • Nitric oxide delivery system, secondary

LungFit PH NDM Assembly Kit - B882900140

The Nitric Oxide Delivery Module (NDM) measures gas flow in the ventilator breathing circuit (flow sensor) and delivers nitric oxide gas mixture into the inspiratory limb of the ventilator breathing circuit (injector line and adapter). The NDM is placed close to the ventilator gas outlet (at least 6 inches/15 cm from the ventilator inspiratory outlet and before the humidifier) to allow for proper mixing of nitric oxide enriched gas from the NDM with the ventilator delivered gas flow. NDM Assembly, comprised of NO Injector Adapter and Tubing, Flow Sensor. Flow enters the flow sensor and exits through the injector adapter. The disposable, single use NDM flow sensor provides a bidirectional, high speed/high accuracy, real time measurement of gas flow in the ventilator breathing circuit, allowing for proper calculation of the required nitric oxide flow output needed to maintain the set NO concentration. NDM kit components, except for the NDM Cable, to be used on one patient only.
Beyond Air, Inc.
90014
In Commercial Distribution

  • B882900141 ()
  • B882900140 ()
  • B882900142 ()


  • Nitric oxide delivery system, secondary

LungFit PH NO2 Bagging Filter - B882900090

There are two NO2 filters in the LungFit PH; the main 12 hr NO2 filter (p/n 90008) that the user can change and the internal bagging 48 hr NO2 filter p/n 90009). The purpose of the NO2 filters is to remove NO2 from the NO gas flow and to collect any particulates that may be in the gas flow path. When the main 12 hr filter is inserted, this NO2 filter communicates with the LungFit device through an RFID wireless chip that is mounted on the filter. The RFID chip on the filter tracks and updates with the filter’s remaining usage time to prevent the filter from being accidently re-used after it has been consumed. The RFID also communicates wirelessly with the Gas Monitoring CPU, as described below. The NO2 filter includes two 1µm filters and two 5µm filters, with the NO2 filter material Sofnolime (soda lime) sandwiched between the particulate filters. Soda lime is a material that is commonly used in anesthesia CO2 absorbers. The duration of use for each main filter is pre-established as 12 hours. The RFID tag tracks filter usage so that the remaining time is updated continually every minute and displayed on the device user interface (i.e., as Time Remaining). The Gas Monitoring CPU detects whether a filter is installed and displays the Change Filter alarm to alert the user to change/insert a new user when no NO2 filter is present. The device also displays the Change Filter alarm when the NO2 filter has been consumed (no more minutes remaining). The internal Bagging NO2 filter is the same basic design as the main NO2 filter that is inserted on the front of the device. The bagging NO2 filter’s useful life is 48 hours because the concentration of NO delivered through this filter is always 20 ppm at 10 L/min whereas up to 80ppm NO can be delivered through the main NO2 filter (or four times more than the backup system). The filter time remaining is tracked in the backup delivery microprocessors nonvolatile memory instead of on a RFID tag like the main NO2 Filter.
Beyond Air, Inc.
90009
In Commercial Distribution

  • B882900091 ()
  • B882900090 ()
  • B882900092 ()


  • Nitric oxide delivery system, secondary

LungFit PH NO2 Filter - B882900080

There are two NO2 filters in the LungFit PH; the main 12 hr NO2 filter (p/n 90008) that the user can change and the internal bagging 48 hr NO2 filter p/n 90009). The purpose of the NO2 filters is to remove NO2 from the NO gas flow and to collect any particulates that may be in the gas flow path. When the main 12 hr filter is inserted, this NO2 filter communicates with the LungFit device through an RFID wireless chip that is mounted on the filter. The RFID chip on the filter tracks and updates with the filter’s remaining usage time to prevent the filter from being accidently re-used after it has been consumed. The RFID also communicates wirelessly with the Gas Monitoring CPU, as described below. The NO2 filter includes two 1µm filters and two 5µm filters, with the NO2 filter material Sofnolime (soda lime) sandwiched between the particulate filters. Soda lime is a material that is commonly used in anesthesia CO2 absorbers. The duration of use for each main filter is pre-established as 12 hours. The RFID tag tracks filter usage so that the remaining time is updated continually every minute and displayed on the device user interface (i.e., as Time Remaining). The Gas Monitoring CPU detects whether a filter is installed and displays the Change Filter alarm to alert the user to change/insert a new user when no NO2 filter is present. The device also displays the Change Filter alarm when the NO2 filter has been consumed (no more minutes remaining).
Beyond Air, Inc.
90008
In Commercial Distribution

  • B882900081 ()
  • B882900080 ()
  • B882900082 ()


  • Nitric oxide delivery system, secondary

15mm Gas Sample Adaptor Kit - B882900070

90007 is a kit containing two off-the-shelf components: - 1: (61920) 15M-15F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 15mm-diameter breathing circuit.
Beyond Air, Inc.
90007
In Commercial Distribution

  • B882900071 ()
  • B882900070 ()
  • B882900072 ()


  • Nitric oxide delivery system, secondary

10mm Gas Sample Adaptor - B882900060

90006 is a kit containing two off-the-shelf components. - 1: (61922) 10M-10F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 10mm-diameter breathing circuit.
Beyond Air, Inc.
90006
In Commercial Distribution

  • B882900061 ()
  • B882900060 ()
  • B882900062 ()


  • Nitric oxide delivery system, secondary

LungFit PH Bagging Kit - B882900050

The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system. When the Selector Switch is turned to “Bagging System” position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient.
Beyond Air, Inc.
90005
In Commercial Distribution

  • B882900051 ()
  • B882900050 ()
  • B882900052 ()


  • Nitric oxide delivery system, secondary

PHAKOS - B564MVLV41HR0

HR Wide angle lens Consultation
PHAKOS
MV LV 41 HR
In Commercial Distribution

  • B564MVLV41HR2 ()
  • B564MVLV41HR0 ()
  • B564MVLV41HR4 ()
MV LV 41 HR

  • Vitrectomy contact lens, single-use

PHAKOS - B564MVCY1000

Disposable Retinal Cryo Probe
PHAKOS
MV CY 100
In Commercial Distribution

  • B564MVCY1000 ()
  • B564MVCY1002 ()
  • B564MVCY1004 ()
MV CY 100

  • General cryosurgical system, cryogen gas, mechanical

Movement and Compressions System (MAC) - B547RF14230

MAC Strap-petite
Recovery Force, LLC
1
In Commercial Distribution

  • B547RF14230 ()
  • B547RF14237 ()
  • B547RF144023 ()

  • Length: 432 Millimeter
RF1423

  • Intermittent venous compression system

Movement and Compressions System (MAC) - B547RF14220

MAC Strap-Bariatric
Recovery Force, LLC
4
In Commercial Distribution

  • B547RF14227 ()
  • B547RF14220 ()
  • B547RF14402270 ()

  • Length: 921 Millimeter
RF1422

  • Intermittent venous compression system

Movement and Compressions System (MAC) - B547RF14210

MAC Strap-XL
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14217 ()
  • B547RF14210 ()
  • B547RF1440219 ()

  • Length: 743 Millimeter
RF1421

  • Intermittent venous compression system

Movement and Compressions System (MAC) - B547RF14200

MAC Strap-Standard
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14208 ()
  • B547RF14200 ()
  • B547RF1440209 ()

  • Length: 565 Millimeter
RF1420

  • Intermittent venous compression system

JK-RUSA - B5331181200

No Description
BLV Licht- und Vakuumtechnik GmbH
400 R7s
In Commercial Distribution

  • B5331181201 ()
  • B5331181200 ()
  • B5331181202 ()
  • B5331081960 ()
118120

  • Ultraviolet tanning device

JK-RUSA - B5331081960

No Description
BLV Licht- und Vakuumtechnik GmbH
400W R7s
In Commercial Distribution

  • B5331081961 ()
  • B5331081960 ()
  • B5331081962 ()
108196

  • Ultraviolet tanning device

Endure - B531YSBVS20

Yankauer Suction Handle, with Bulbous Tip, Vented, Sterile
ENDURE INDUSTRIES
YSBVS21217
In Commercial Distribution

  • B531YSBVS20 ()
  • B531YSBVS21 ()
  • B531YSBVS22 ()
YSBVS2

  • Suction cannula, single-use

Endure - B531YSBNS20

Yankauer Suction Handle, with Bulbous Tip, Non-Vented, Sterile
ENDURE INDUSTRIES
YSBNS21217
In Commercial Distribution

  • B531YSBNS20 ()
  • B531YSBNS21 ()
  • B531YSBNS22 ()
YSBNS2

  • Suction cannula, single-use

Endure - B531OA920

Oropharyngeal Airway, Size 90 mm (Manufacture's Size "3"), Non-Sterile
ENDURE INDUSTRIES
OA921217
In Commercial Distribution

  • B531OA922 ()
  • B531OA921 ()
  • B531OA920 ()

  • Length: 90 Millimeter
OA92

  • Oropharyngeal airway, single-use

Endure - B531OA820

Oropharyngeal Airway, Size 80 mm, Non-Sterile
ENDURE INDUSTRIES
OA821217
In Commercial Distribution

  • B531OA822 ()
  • B531OA821 ()
  • B531OA820 ()

  • Length: 80 Millimeter
OA82

  • Oropharyngeal airway, single-use

Endure - B531OA720

Oropharyngeal Airway, Size 70, Non-Sterile
ENDURE INDUSTRIES
OA721217
In Commercial Distribution

  • B531OA722 ()
  • B531OA721 ()
  • B531OA720 ()

  • Length: 70 Millimeter
OA72

  • Oropharyngeal airway, single-use

Endure - B531OA620

Oropharyngeal Airway, Size 60, Non-Sterile
ENDURE INDUSTRIES
OA621217
In Commercial Distribution

  • B531OA622 ()
  • B531OA621 ()
  • B531OA620 ()

  • Length: 60 Millimeter
OA62

  • Oropharyngeal airway, single-use

Endure - B531OA520

Oropharyngeal Airway, Size 50, Non-Sterile
ENDURE INDUSTRIES
OA521217
In Commercial Distribution

  • B531OA522 ()
  • B531OA521 ()
  • B531OA520 ()

  • Length: 50 Millimeter
OA52

  • Oropharyngeal airway, single-use

Endure - B531OA420

Oropharyngeal Airway, Size 40, Non-Sterile
ENDURE INDUSTRIES
OA421217
In Commercial Distribution

  • B531OA422 ()
  • B531OA421 ()
  • B531OA420 ()

  • Length: 40 Millimeter
OA42

  • Oropharyngeal airway, single-use

Endure - B531OA1220

Oropharyngeal Airway, Size 120 mm, Non-Sterile
ENDURE INDUSTRIES
OA1221217
In Commercial Distribution

  • B531OA1222 ()
  • B531OA1221 ()
  • B531OA1220 ()

  • Length: 120 Millimeter
OA122

  • Oropharyngeal airway, single-use

Endure - B531OA1120

Oropharyngeal Airway, Size 110 mm, Non-Sterile
ENDURE INDUSTRIES
OA1121217
In Commercial Distribution

  • B531OA1122 ()
  • B531OA1121 ()
  • B531OA1120 ()

  • Length: 110 Millimeter
OA112

  • Oropharyngeal airway, single-use

Endure - B531OA1020

Oropharyngeal Airway, Size 100 mm, Non-Sterile
ENDURE INDUSTRIES
OA1021217
In Commercial Distribution

  • B531OA1022 ()
  • B531OA1021 ()
  • B531OA1020 ()

  • Length: 100 Millimeter
OA102

  • Oropharyngeal airway, single-use

Endure - B531NPS3420

Nasopharyngeal Airway, Size = 34 Fr, Internal Diameter 7.5 inches
ENDURE INDUSTRIES
NPS3421217
In Commercial Distribution

  • B531NPS3420 ()
  • B531NPS3421 ()
  • B531NPS3422 ()
B531NPS342

  • Nasopharyngeal airway, single-use

Endure - B531NPS3220

Nasopharyngeal Airway, Size = 32 Fr, Internal Diameter 7 inches
ENDURE INDUSTRIES
NPS3221217
In Commercial Distribution

  • B531NPS3220 ()
  • B531NPS3221 ()
  • B531NPS3222 ()
NPS322

  • Nasopharyngeal airway, single-use

Endure - B531NPS3020

Nasopharyngeal Airway, Size = 30 Fr, Internal Diameter 6.5 inches
ENDURE INDUSTRIES
NPS3021217
In Commercial Distribution

  • B531NPS3020 ()
  • B531NPS3021 ()
  • B531NPS3022 ()
NPS302

  • Nasopharyngeal airway, single-use

Endure - B531NPS2820

Nasopharyngeal Airway, Size = 28 Fr, Internal Diameter 6 inches
ENDURE INDUSTRIES
NPS2821217
In Commercial Distribution

  • B531NPS2820 ()
  • B531NPS2821 ()
  • B531NPS2822 ()
NPS282

  • Nasopharyngeal airway, single-use
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