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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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Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Jiangxi Aicare Medical Technology Co., Ltd.
X8
In Commercial Distribution

  • 06972480913269 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Jiangxi Aicare Medical Technology Co., Ltd.
X11
In Commercial Distribution

  • 06972480913054 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Jiangxi Aicare Medical Technology Co., Ltd.
X7
In Commercial Distribution

  • 06972480913030 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
The xReader System consists of a small, portable high resolution flatbed scanner, customized Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The xReader System is intended for use with the xCup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine. The xReader System detects drug classes at the following cutoff concentrations: Amphetamines at 500 ng/mL; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCup may consist of any combination of the listed drug analytes. The xCup test devices are run in the xReader System according to their specific instructions for use. At the conclusion of the test an image is captured and the Software determines whether the colored test lines for each analyte are above or below the threshold associated with a Send to Lab or a Discard result. The Software also confirms the validity of the results by verifying the presence of control lines and analyzing the specimen validity. The xReader System is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use. The xCup test devices cannot be read visually.
ESCREEN, INC.
BS-0610S
In Commercial Distribution

  • 00867802000290 ()
301

  • Photometric/spectroscopic immunoassay analyser IVD
Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, minus 6" length, patented Size M
Lac-Mac Limited
005XFAQ-M
In Commercial Distribution

  • 00627755531124 ()

  • Height: 57.25 Inch
005XFAQ-M

  • Surgical gown, reusable
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/405nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 Revi
In Commercial Distribution

  • 00852116008186 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 ProZ
In Commercial Distribution

  • 00852116008179 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/405nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-Revi
Not in Commercial Distribution

  • 00852116008087 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 0.8 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-Home
Not in Commercial Distribution

  • 00852116008070 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProX
Not in Commercial Distribution

  • 00852116008063 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProZ
Not in Commercial Distribution

  • 00852116008056 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 0.8 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-P
Not in Commercial Distribution

  • 00852116008025 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-X
Not in Commercial Distribution

  • 00852116008018 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-Z
Not in Commercial Distribution

  • 00852116008001 ()


  • Musculoskeletal/physical therapy laser, professional
McCabe Measuring Instrument Slightly Curved Round Shaft With Calibrations At 3mm, 4mm And 5m; Overall Length 6-1/8in (15.6cm)
Med Saver, Inc.
121-23941BX
In Commercial Distribution

  • 00194613116965 ()


  • Medical ruler, reusable
K-wire Ø1.6 mm, length 300 mm, trocar tip, measuring ring at 150 mm, for 4/4.5 mm cannulated screws
Bioretec Oy
B-ISC-1602
In Commercial Distribution

  • E302BISC16029 ()

  • Width: 1.6 Millimeter
  • Length: 300 Millimeter
B-ISC-1602

  • Orthopaedic bone wire
Adult, Vidal volume Range (150-1500mL), Breathing Resistance (1.7cm H2O at 60L/min), Media (Foam), Dead Space (55mL), Weight (28.5g)
Dynarex Corporation
30102
In Commercial Distribution

  • 00840117305854 ()
  • 00840117305847 ()


  • Heat/moisture exchanger/microbial medical gas filter
Adult, Tidal Volume Range(150-1250mL), Media(Foam), Dead Space(16mL), Breathing Resistance(0.2cm H2O at 60L/min), Weight (5.6g)
Dynarex Corporation
30300
In Commercial Distribution

  • 00840117305519 ()
  • 00840117305526 ()


  • Heat/moisture exchanger/microbial medical gas filter
Tidal Volume Range(5-50mL), Media(Foam), Dead Space(2.2mL), Breathing Resistance(2.0cm H2O at 30 L/min), Weight(1.6g)
Dynarex Corporation
30210
In Commercial Distribution

  • 00840117305502 ()
  • 00840117305496 ()


  • Heat/moisture exchanger/microbial medical gas filter
Maumenee colibri forceps, 4 1/8'', very delicate 0.12mm 1x2 teeth set at 45 degrees, cross-action round handle, titanium
AMBLER SURGICAL CORP.
Maumenee colibri forceps
In Commercial Distribution

  • 00190660063498 ()
9557T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
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