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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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Vitale Sacral Silicone Foam Dressing, 7" x 6 3/4", 5/box, 10 boxes/case
CELLERA LLC
20190
Not in Commercial Distribution

  • B492201901 ()
  • B492201900 ()
  • B492201903 ()
20190

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Silicone Foam Dressings, 3" X 3", 10/box, 10 boxes/case
CELLERA LLC
20133
Not in Commercial Distribution

  • B492201332 ()
  • B492201331 ()
  • B492201330 ()
20133

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH.
Beyond Air, Inc.
90031
In Commercial Distribution

  • B882900310 ()
  • B882900311 ()
  • B882900312 ()


  • Nitric oxide delivery system, secondary
90017 is a kit containing two off-the-shelf components: - 1: (61928) 22M-22F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 22mm-diameter breathing circuit.
Beyond Air, Inc.
90017
In Commercial Distribution

  • B882900171 ()
  • B882900170 ()
  • B882900172 ()


  • Nitric oxide delivery system, secondary
The Luer elbow is a component to the gas sampling port which fits on a breathing circuit.
Beyond Air, Inc.
90016
In Commercial Distribution

  • B882900161 ()
  • B882900160 ()
  • B882900162 ()


  • Nitric oxide delivery system, secondary
Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT
Not in Commercial Distribution

  • B056CLRCT2 ()
  • B056CLRCT1 ()
  • B056CLRCT0 ()
  • B056CLRCT5 ()
CL-R-CT

  • Assisted reproduction vitrification carrier
Single use vaginal speculum with built in light source size small
FTT MEDICAL, INC.
140310
In Commercial Distribution

  • B3961403102 ()
  • B3961403100 ()
  • B3961403101 ()
14-0310

  • Vaginal speculum, single-use
No Description
MEDITECH SPINE, LLC
S1-9-42460-60
In Commercial Distribution

  • B167S4942460602 ()
  • B167S2942460601 ()
  • B167S1942460600 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-9-42460-55
In Commercial Distribution

  • B167S4942460552 ()
  • B167S2942460551 ()
  • B167S1942460550 ()


  • Spinal bone screw, non-bioabsorbable
No Description
MEDITECH SPINE, LLC
S1-9-42460-50
In Commercial Distribution

  • B167S2942460501 ()
  • B167S4942460502 ()
  • B167S1942460500 ()


  • Spinal bone screw, non-bioabsorbable
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