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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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Endure - B531ETPOC5060

Preformed Endotracheal Tube, Oral, Cuffed, Size = 5.0 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC5061017
In Commercial Distribution

  • B531ETPOC5062 ()
  • B531ETPOC5061 ()
  • B531ETPOC5060 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
ETPOC506

  • Basic endotracheal tube, single-use

Endure - B531ETPOC4560

Preformed Endotracheal Tube, Oral, Cuffed, Size = 4.5 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC4561017
In Commercial Distribution

  • B531ETPOC4560 ()
  • B531ETPOC4561 ()
  • B531ETPOC4562 ()

  • Lumen/Inner Diameter: 4.5 Millimeter
ETPOC456

  • Basic endotracheal tube, single-use

Endure - B531ETPOC4060

Preformed Endotracheal Tube, Oral, Cuffed, Size = 4.0 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC4061017
In Commercial Distribution

  • B531ETPOC4062 ()
  • B531ETPOC4061 ()
  • B531ETPOC4060 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
ETPOC406

  • Basic endotracheal tube, single-use

Endure - B531ETPNC7560

Endotracheal Tube, Preformed, Nasal, Cuffed, Size 7.5 mm internal diameter
ENDURE INDUSTRIES
ETPNC7561017
In Commercial Distribution

  • B531ETPNC7562 ()
  • B531ETPNC7561 ()
  • B531ETPNC7560 ()

  • Lumen/Inner Diameter: 7.5 Millimeter
ETPNC756

  • Basic endotracheal tube, single-use

Endure - B531ETPNC7060

Endotracheal Tube, Preformed, Nasal, Cuffed, Size 7.0 mm Internal Diameter, Sterile
ENDURE INDUSTRIES
ETPNC7061017
In Commercial Distribution

  • B531ETPNC7062 ()
  • B531ETPNC7061 ()
  • B531ETPNC7060 ()

  • Lumen/Inner Diameter: 7.0 Millimeter
ETPNC706

  • Basic endotracheal tube, single-use

Endure - B531ETPNC6560

Endotracheal Tube, Preformed, Nasal, Cuffed, Size 6.5 mm Internal Diameter, Sterile
ENDURE INDUSTRIES
ETPNC6561017
In Commercial Distribution

  • B531ETPNC6562 ()
  • B531ETPNC6561 ()
  • B531ETPNC6560 ()

  • Lumen/Inner Diameter: 6.5 Millimeter
ETPNC656

  • Basic endotracheal tube, single-use

Endure - B531ETPNC6060

Endotracheal Tube, Preformed, Nasal, Cuffed, Size 6.0 mm Internal Diameter, Sterile
ENDURE INDUSTRIES
ETPNC6061017
In Commercial Distribution

  • B531ETPNC6062 ()
  • B531ETPNC6061 ()
  • B531ETPNC6060 ()

  • Lumen/Inner Diameter: 6.0 Millimeter
ETPNC606

  • Basic endotracheal tube, single-use

Endure - B531ETNU7550

Endotracheal Tube, Standard Type, Uncuffed, Size = 7.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETNU7551217
In Commercial Distribution

  • B531ETNU7552 ()
  • B531ETNU7551 ()
  • B531ETNU7550 ()

  • Lumen/Inner Diameter: 7.5 Millimeter
ETNU755

  • Basic endotracheal tube, single-use

Endure - B531ETNU7050

Endotracheal Tube, Standard Type, Uncuffed, Size = 7.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNU7051217
In Commercial Distribution

  • B531ETNU7052 ()
  • B531ETNU7051 ()
  • B531ETNU7050 ()

  • Lumen/Inner Diameter: 7.0 Millimeter
ETNU705

  • Basic endotracheal tube, single-use

Endure - B531ETNU5550

Endotracheal Tube, Standard Type, Uncuffed, Size = 5.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETNU5551217
In Commercial Distribution

  • B531ETNU5552 ()
  • B531ETNU5551 ()
  • B531ETNU5550 ()

  • Lumen/Inner Diameter: 5.5 Millimeter
ETNU555

  • Basic endotracheal tube, single-use

Endure - B531ETNU5050

Endotracheal Tube, Standard Type, Uncuffed, Size = 5.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNU5051217
In Commercial Distribution

  • B531ETNU5052 ()
  • B531ETNU5051 ()
  • B531ETNU5050 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
ETNU505

  • Basic endotracheal tube, single-use

Endure - B531ETNU4550

Endotracheal Tube, Standard Type, Uncuffed, Size = 4.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETNU4551217
In Commercial Distribution

  • B531ETNU4552 ()
  • B531ETNU4551 ()
  • B531ETNU4550 ()

  • Lumen/Inner Diameter: 4.5 Millimeter
ETNU455

  • Basic endotracheal tube, single-use

Endure - B531ETNU4050

Endotracheal Tube, Standard Type, Uncuffed, Size = 4.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNU4051217
In Commercial Distribution

  • B531ETNU4052 ()
  • B531ETNU4051 ()
  • B531ETNU4050 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
ETNU405

  • Basic endotracheal tube, single-use

Endure - B531ETNU3550

Endotracheal Tube, Standard Type, Uncuffed, Size = 3.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETNU3551217
In Commercial Distribution

  • B531ETNU3552 ()
  • B531ETNU3551 ()
  • B531ETNU3550 ()

  • Lumen/Inner Diameter: 3.5 Millimeter
ETNU355

  • Basic endotracheal tube, single-use

Endure - B531ETNU3050

Endotracheal Tube, Standard Type, Uncuffed, Size = 3.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNU3051217
In Commercial Distribution

  • B531ETNU3052 ()
  • B531ETNU3051 ()
  • B531ETNU3050 ()

  • Lumen/Inner Diameter: 3.0 Millimeter
ETNU305

  • Basic endotracheal tube, single-use

Endure - B531ETNC9050

Endotracheal Tube, Standard Type, Cuffed, Size = 9.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC9051217
In Commercial Distribution

  • B531ETNC9052 ()
  • B531ETNC9051 ()
  • B531ETNC9050 ()

  • Lumen/Inner Diameter: 9.0 Millimeter
ETNC905

  • Basic endotracheal tube, single-use

Endure - B531ETNC8550

Endotracheal Tube, Standard Type, Cuffed, Size = 8.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC8551217
In Commercial Distribution

  • B531ETNC8552 ()
  • B531ETNC8551 ()
  • B531ETNC8550 ()

  • Lumen/Inner Diameter: 8.5 Millimeter
ETNC855

  • Basic endotracheal tube, single-use

Endure - B531ETNC8050

Endotracheal Tube, Standard Type, Cuffed, Size = 8.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC8051217
In Commercial Distribution

  • B531ETNC8052 ()
  • B531ETNC8051 ()
  • B531ETNC8050 ()

  • Lumen/Inner Diameter: 8.0 Millimeter
ETNC805

  • Basic endotracheal tube, single-use

Endure - B531ETNC7550

Endotracheal Tube, Standard Type, Cuffed, Size = 7.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC7551217
In Commercial Distribution

  • B531ETNC7552 ()
  • B531ETNC7551 ()
  • B531ETNC7550 ()

  • Lumen/Inner Diameter: 7.5 Millimeter
ETNC755

  • Basic endotracheal tube, single-use

Endure - B531ETNC7050

Endotracheal Tube, Standard Type, Cuffed, Size = 7 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC7051217
In Commercial Distribution

  • B531ETNC7052 ()
  • B531ETNC7051 ()
  • B531ETNC7050 ()

  • Lumen/Inner Diameter: 7.0 Millimeter
ETNC705

  • Basic endotracheal tube, single-use

Endure - B531ETNC6550

Endotracheal Tube, Standard Type, Cuffed, Size = 6.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC6551217
In Commercial Distribution

  • B531ETNC6552 ()
  • B531ETNC6551 ()
  • B531ETNC6550 ()

  • Lumen/Inner Diameter: 6.5 Millimeter
ETNC655

  • Basic endotracheal tube, single-use

Endure - B531ETNC6050

Endotracheal Tube, Standard Type, Cuffed, Size = 6 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC6051217
In Commercial Distribution

  • B531ETNC6052 ()
  • B531ETNC6051 ()
  • B531ETNC6050 ()

  • Lumen/Inner Diameter: 6.0 Millimeter
ETNC605

  • Basic endotracheal tube, single-use

Endure - B531ETNC5550

Endotracheal Tube, Standard Type, Cuffed, Size = 5.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC5551217
In Commercial Distribution

  • B531ETNC5550 ()
  • B531ETNC5551 ()
  • B531ETNC5552 ()

  • Lumen/Inner Diameter: 5.5 Millimeter
ETNC555

  • Basic endotracheal tube, single-use

Endure - B531ETNC5050

Endotracheal Tube, Standard Type, Cuffed, Size = 5.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC5051217
In Commercial Distribution

  • B531ETNC5052 ()
  • B531ETNC5051 ()
  • B531ETNC5050 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
ETNC505

  • Basic endotracheal tube, single-use

Endure - B531ETNC4550

Endotracheal Tube, Standard Type, Cuffed, Size = 4.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC4551217
In Commercial Distribution

  • B531ETNC4550 ()
  • B531ETNC4551 ()
  • B531ETNC4552 ()

  • Lumen/Inner Diameter: 4.5 Millimeter
ETNC455

  • Basic endotracheal tube, single-use

Endure - B531ETNC4050

Endotracheal Tube, Standard Type, Cuffed, Size = 4.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC4051217
In Commercial Distribution

  • B531ETNC4052 ()
  • B531ETNC4051 ()
  • B531ETNC4050 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
ETNC405

  • Basic endotracheal tube, single-use

Endure - B531ES1450

Endotracheal Stylet, Size= 14 Fr, fits endotracheal tubes of sizes internal diameter > 5.5mm.
ENDURE INDUSTRIES
ES1451217
In Commercial Distribution

  • B531ES1452 ()
  • B531ES1451 ()
  • B531ES1450 ()

  • Size- 14 Fr
ES145

  • Artificial airway stylet, single-use

Endure - B531ES1050

Endotracheal Stylet, size= 10Fr, fits endotracheal tubes of sizes internal diameter 4-5 mm.
ENDURE INDUSTRIES
ES1051217
In Commercial Distribution

  • B531ES1052 ()
  • B531ES1051 ()
  • B531ES1050 ()

  • size- 10Fr
ES105

  • Artificial airway stylet, single-use

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

DCTclock - B626100030

DCTclock Test Form - Research
Linus Health, Inc.
10003
In Commercial Distribution

  • B626100030 ()
  • B626100031 ()
  • B626100032 ()
10003

  • Drawing-test cognitive function analysis device

Vios Monitoring System Pulse Oximetry Sensor - B595L2050R0

The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution

  • B595L2050R0 ()
  • B595L2050R1 ()
  • B595L2050R2 ()
L2050R

  • Pulse oximeter probe, reusable
  • Pulse Co-oximeter probe, reusable

DCTclock - B626100720

DCTclock Test Form - Clinical
Linus Health, Inc.
10072
In Commercial Distribution

  • B626100722 ()
  • B626100721 ()
  • B626100720 ()
10072

  • Drawing-test cognitive function analysis device

Lithotomy Drape - B6143511011

The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barrier for the patient and isolates the surgical site. The Lithotomy Drape also provides a sterile barrier between transurethral and rectal instruments, while also managing fluid collection. The Lithotomy Drape allows the physician to conduct an Aquablation® or other transurethral or transrectal urological procedures and reduce the risk of breaching sterility. The Lithotomy Drape, measuring 105 inches by 53 inches, is made of a Non-woven SMS textile, transparent poly sheeting, and a fluid pouch with a mesh screen.
PROCEPT BIOROBOTICS CORPORATION
351101
In Commercial Distribution

  • B6143511011 ()
  • B6143511018 ()
  • B6143511012 ()
351101

  • Patient surgical drape, single-use

Gesiva Medical - B598GMMHT0001

No Description
GESIVA MEDICAL LLC
Medium High Tension Ring
In Commercial Distribution

  • B598GMMHT0001 ()
  • B598GMMHT0002 ()
  • B598GMTRK0001 ()


  • Penile vacuum device

MicroLyte Ag - B519910020

Gelling fiber wound dressing, 4"x4"
IMBED BIOSCIENCES, INC
91002
Not in Commercial Distribution

  • B519910022 ()
  • B519910021 ()
  • B519910020 ()

  • Area/Surface Area: 16 Square inch
91002

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

Microlyte AG - B519910010

Gelling fiber wound dressing, 2" x 2"
IMBED BIOSCIENCES, INC
91001
Not in Commercial Distribution

  • B519910012 ()
  • B519910011 ()
  • B519910010 ()

  • Area/Surface Area: 4 Square inch
91001

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

CitriSol - B467CS8022510200

CitriSol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CS80225-10200
In Commercial Distribution

  • B467CS80225102004 ()
  • B467CS8022510200 ()
  • B467CS802251020055 ()
CSG7

  • Haemodialysis concentrate

CitriSol - B467CS10033010100

CitriSol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CS100330-10100
In Commercial Distribution

  • B467CS100330101004 ()
  • B467CS10033010100 ()
  • B467CS1003301010055 ()
CSG6

  • Haemodialysis concentrate

CitriSol - B467CS10032510100

CitriSol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CS100325-10100
In Commercial Distribution

  • B467CS100325101004 ()
  • B467CS10032510100 ()
  • B467CS1003251010055 ()
CSD2-CSG5

  • Haemodialysis concentrate

CitriSol - B467CS10022575100

CitriSol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CS100225-75100
In Commercial Distribution

  • B467CS100225751004 ()
  • B467CS10022575100 ()
  • B467CS1002257510055 ()
CSG4

  • Haemodialysis concentrate

CitriSol - B467CS10022510100

CitriSol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CS100225-10100
In Commercial Distribution

  • B467CS1002251010055 ()
  • B467CS10022510100 ()
  • B467CS100225101004 ()
CSD1-CSG3

  • Haemodialysis concentrate

CitriSol - B467CS10012510100

CitriSol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CS100125-10100
In Commercial Distribution

  • B467CS100125101004 ()
  • B467CS10012510100 ()
  • B467CS1001251010055 ()
CSG2

  • Haemodialysis concentrate

CitriSol - B467CS10000010100

CitriSol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CS100000-10100
In Commercial Distribution

  • B467CS100000101004 ()
  • B467CS10000010100 ()
  • B467CS1000001010055 ()
CSG1

  • Haemodialysis concentrate

DIASOL - B467BP4512

Diasol Sodium Bicarbonate Powder
DIASOL, INC.
BP10000X12
In Commercial Distribution

  • B467BP4512 ()
  • B467BP5612T1 ()
  • B467BP4512T3 ()
BP6/7

  • Haemodialysis concentrate

DIASOL - B467BP4510

Diasol Sodium Bicarbonate Powder
DIASOL, INC.
BP10000X10
In Commercial Distribution

  • B467BP4510 ()
  • B467BP4510T1 ()
  • B467BP4510T3 ()
BP4/5

  • Haemodialysis concentrate

DRYASOL - B467ACP4512575100

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45125-75100
In Commercial Distribution

  • B467ACP451257510016 ()
  • B467ACP4512575100 ()
  • B467ACP451257510025 ()
ACP6/7

  • Haemodialysis concentrate

DRYASOL - B467ACP3623510200

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
36235-10200
In Commercial Distribution

  • B467ACP362351020025 ()
  • B467ACP3623510200 ()
  • B467ACP362351020033 ()
ACP4

  • Haemodialysis concentrate

DIASOL - B4678042510200

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
80425-10200
In Commercial Distribution

  • B467804251020055 ()
  • B4678042510200 ()
  • B46780425102004 ()
ACD46-ACG89

  • Haemodialysis concentrate

DIASOL - B4678033010200

Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
DIASOL, INC.
80330-10200
In Commercial Distribution

  • B467803301020055 ()
  • B4678033010200 ()
  • B46780330102004 ()
ACG88

  • Haemodialysis concentrate
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