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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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UltraFlo Insulin Syringe - B7442259361

0.3 ML 31GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225936
In Commercial Distribution

  • B7442259363 ()
  • B7442259362 ()
  • B7442259361 ()
  • B7442259360 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259351

0.3 ML 30GX5/16" 1/2 UNIT MARKING
QUALITY MEDICAL PRODUCTS USA, INC.
225935
In Commercial Distribution

  • B7442259353 ()
  • B7442259352 ()
  • B7442259351 ()
  • B7442259350 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259341

0.3 ML 30GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225934
In Commercial Distribution

  • B7442259343 ()
  • B7442259342 ()
  • B7442259341 ()
  • B7442259340 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259331

0.3 ML 30GX1/2" 1/2 UNIT MARKING
QUALITY MEDICAL PRODUCTS USA, INC.
225933
In Commercial Distribution

  • B7442259333 ()
  • B7442259332 ()
  • B7442259331 ()
  • B7442259330 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259321

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

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


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259311

0.3 ML 29GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225931
In Commercial Distribution

  • B7442259313 ()
  • B7442259312 ()
  • B7442259311 ()
  • B7442259310 ()


  • Insulin syringe/needle, basic

BodyTrace - B726BT1060

Upper arm blood pressure monitor.
BODYTRACE, INC
BT106
In Commercial Distribution

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


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Omada - B726BT105O0

Upper arm blood pressure monitor.
BODYTRACE, INC
BT105O
In Commercial Distribution

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


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

BodyTrace - B726BT1050

Upper arm blood pressure monitor.
BODYTRACE, INC
BT105
In Commercial Distribution

  • B726BT1051 ()
  • B726BT1050 ()
  • B726BT1052 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Omada - B726BT104O0

Upper arm blood pressure monitor.
BODYTRACE, INC
BT104O
In Commercial Distribution

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


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

BodyTrace - B726BT1040

Upper arm blood pressure monitor.
BODYTRACE, INC
BT104
In Commercial Distribution

  • B726BT1042 ()
  • B726BT1041 ()
  • B726BT1040 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

BodyTrace - B726BT0060

Weight scale.
BODYTRACE, INC
BT006
In Commercial Distribution

  • B726BT0061 ()
  • B726BT0060 ()
  • B726BT0062 ()


  • Stand-on floor scale, electronic

Vida - B726BT005V0

Weight scale.
BODYTRACE, INC
BT005
In Commercial Distribution

  • B726BT005V1 ()
  • B726BT005V0 ()
  • B726BT005V2 ()


  • Stand-on floor scale, electronic

Omada - B726BT005O0

Weight scale.
BODYTRACE, INC
BT005
In Commercial Distribution

  • B726BT005O1 ()
  • B726BT005O0 ()
  • B726BT005O2 ()


  • Stand-on floor scale, electronic

BodyTrace - B726BT0050

Weight scale.
BODYTRACE, INC
BT005
In Commercial Distribution

  • B726BT0051 ()
  • B726BT0050 ()
  • B726BT0052 ()


  • Stand-on floor scale, electronic

DCTclock - B626100720

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

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

  • Drawing-test cognitive function analysis device

DCTclock - B626100030

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

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

  • 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

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

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
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