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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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For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.
Atos Medical AB
7704
In Commercial Distribution

  • 07331791016721 ()
  • 07331791002861 ()
7704

  • Tracheostoma protective filter
Near Infrared phototherapy device emitting up to 45 W at 980 nm, 12.1 Inch LCD Touch Screen display
Fotonmedix Medical Laser Co., LTD
LaserMedix4500U1
In Commercial Distribution

  • 06976487170007 ()


  • Musculoskeletal/physical therapy laser, professional
VOMIT AND URINE CLEAR BAG (EMESIS) WITH INNER LEAK PROOF VALVE AND 6" RIGID OPENING AT THE TOP
KENTRON HEALTHCARE, INC.
404086
In Commercial Distribution

  • 00810003751225 ()
  • 00810003751218 ()
  • 00810003751232 ()
404086

  • Emesis bag
R195 - The PDT 12 Probe is a single-end probe with markings at 3-6-9-12mm coupled with a mobility probe.
PDT, INC.
R195 Probe 12 (3-6-9-12)
In Commercial Distribution

  • 00813677021199 ()
R195

  • Dental surgical probe, reusable
R194 - The PDT 11 Probe is a single-end probe with markings at 3-6-8-11mm coupled with a mobility probe.
PDT, INC.
R194 Probe 11 (3-6-8-11)
In Commercial Distribution

  • 00813677021182 ()
R194

  • Dental surgical probe, reusable
cooley anastomosis clamp, jaws calibrated at 5.0 mm intervals, 6 1/2" (16.5 cm), 7.0 mm jaw depth
NOVO SURGICAL, INC.
5560-11
Not in Commercial Distribution

  • 00842331118586 ()

  • Length: 16.5 Centimeter


  • Vascular Doppler clamp
Provent 30 Night Starter Kit contains two (2) Light resistance (Phase 1) non-therapeutic acclimation units, two (2) Medium resistance (Phase 2) non-therapeutic acclimation units, and 26 Standard resistance Provent devices
PROVENT SLEEP THERAPY, LLC
CAT1114
In Commercial Distribution

  • 00868020000215 ()

  • Expiratory Resistance 0.5 >= x <1.5 cm H2O at 50 mL/sec flow rate per nostril
  • Expiratory Resistance 1.5 >= x <3.0 cm H2O at 50 mL/sec flow rate per nostril
  • Expiratory Resistance 3.0 >= x <8.0 cm H2O at 50 mL/sec flow rate per nostril
CAT1114

  • Nasal dilator
The First Device featuring PRISM Technology. Global patent including US Patent No. US 7.841.224 B2 & US 8.250.900 B2, Accuracy: +/- 0.01 at 0.10 g/dL (%BAC), Sensor module must be replaced every 200 tests or at least once yearly, whichever comes first.
AK Globaltech Corp
SM6000
In Commercial Distribution

  • 00853464001089 ()
AKG SM6000

  • Alcohol breath analyser
Koch Mendez Fixation Ring, beveled degree gauge with teeth, handle mounted at 135 degrees, works well with our E3-4011, 5 degree ruler markings on top of unique bevel (labeled at 30 degree increments), round knurled handle, Titanium (with stainless color)
Hayden Medical, Inc.
E3-4069T
In Commercial Distribution

  • 00840319726525 ()
E3-4069T

  • Corneal marker, reusable
Koch Mendez Fixation Ring, Beveled Degree Gauge with teeth, Handle Mounted at 135 Degrees, Works well with our CM-0402, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree increments), Round Knurled Handle, Titanium (with Stainless color)
Crestpoint Management Limited
PH9409T
In Commercial Distribution

  • G412PH9409T0 ()


  • Medical ruler, reusable
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