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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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0.3 ML 30GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225932
In Commercial Distribution

  • B7442259323 ()
  • B7442259322 ()
  • B7442259321 ()
  • B7442259320 ()


  • Insulin syringe/needle, basic
Upper arm blood pressure monitor.
BODYTRACE, INC
BT106
In Commercial Distribution

  • B726BT1061 ()
  • B726BT1060 ()
  • B726BT1062 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Upper arm blood pressure monitor.
BODYTRACE, INC
BT105O
In Commercial Distribution

  • B726BT105O1 ()
  • B726BT105O0 ()
  • B726BT105O2 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Upper arm blood pressure monitor.
BODYTRACE, INC
BT104O
In Commercial Distribution

  • B726BT104O2 ()
  • B726BT104O1 ()
  • B726BT104O0 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
DCTclock Test Form - Clinical
Linus Health, Inc.
10072
In Commercial Distribution

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

  • Drawing-test cognitive function analysis device
DCTclock Test Form - Research
Linus Health, Inc.
10003
In Commercial Distribution

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

  • Drawing-test cognitive function analysis device
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
No Description
GESIVA MEDICAL LLC
Medium High Tension Ring
In Commercial Distribution

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


  • Penile vacuum device
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
Soft Nitrile Powder Free Medical Gloves Size Extra Large
GD CARE INC.
SNM50020E
In Commercial Distribution

  • B754SNM50020E1 ()
  • B754SNM50020E0 ()
  • B754SNM50020E2 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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