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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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15mm Gas Sample Adaptor Kit - B882900070

90007 is a kit containing two off-the-shelf components: - 1: (61920) 15M-15F 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 15mm-diameter breathing circuit.
Beyond Air, Inc.
90007
In Commercial Distribution

  • B882900071 ()
  • B882900070 ()
  • B882900072 ()


  • Nitric oxide delivery system, secondary

10mm Gas Sample Adaptor - B882900060

90006 is a kit containing two off-the-shelf components. - 1: (61922) 10M-10F 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 10mm-diameter breathing circuit.
Beyond Air, Inc.
90006
In Commercial Distribution

  • B882900061 ()
  • B882900060 ()
  • B882900062 ()


  • Nitric oxide delivery system, secondary

LungFit PH Bagging Kit - B882900050

The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system. When the Selector Switch is turned to “Bagging System” position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient.
Beyond Air, Inc.
90005
In Commercial Distribution

  • B882900051 ()
  • B882900050 ()
  • B882900052 ()


  • Nitric oxide delivery system, secondary

MARK3 - D79611771

MAX BITE Bite Registration Mint Chocolate Chip Super Fast - MARK3®*
CARGUS INTERNATIONAL, INC
1177
In Commercial Distribution

  • D79611772 ()
  • D79611771 ()
  • D79611773 ()
  • D796117717 ()
1177

  • Silicone dental impression material

MARK3 - D796117616

Bite Registration Mint Chocolate Chip Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1176
In Commercial Distribution

  • D796117616 ()
  • D7961176 ()
  • D79611762 ()
  • D79611763 ()


  • Silicone dental impression material

MARK3 - D796117313

Bite Registration Hard Bite Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1173
In Commercial Distribution

  • D796117313 ()
  • D7961173 ()
  • D79611732 ()
  • D79611733 ()


  • Silicone dental impression material

MARK3 - D796117212

Bite Registration Super Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1172
In Commercial Distribution

  • D796117212 ()
  • D7961172 ()
  • D79611722 ()
  • D79611723 ()


  • Silicone dental impression material

MARK3 - D796117111

Bite Registration Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1171
In Commercial Distribution

  • D796117111 ()
  • D79611710 ()
  • D79611712 ()
  • D79611713 ()


  • Silicone dental impression material

MARK3 - D796117010

Bite Registration Regular Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1170
In Commercial Distribution

  • D796117010 ()
  • D7961170 ()
  • D79611702 ()
  • D79611703 ()


  • Silicone dental impression material

MARK3 - D796114714

eXact VPS Impression Material Monophase Fast Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1147
In Commercial Distribution

  • D796114714 ()
  • D7961147 ()
  • D79611472 ()
  • D79611473 ()


  • Silicone dental impression material

MARK3 - D796114613

eXact VPS Impression Material Monophase Regular Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1146
In Commercial Distribution

  • D796114613 ()
  • D7961146 ()
  • D79611462 ()
  • D79611463 ()


  • Silicone dental impression material

MARK3 - D796114512

eXact VPS Impression Material Heavy Fast Set 50ml. Cartridge - MARK3
CARGUS INTERNATIONAL, INC
1145
In Commercial Distribution

  • D796114512 ()
  • D79611450 ()
  • D796114513 ()
  • D796114514 ()


  • Silicone dental impression material

MARK3 - D796114411

eXact VPS Impression Material Heavy Regular Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1144
In Commercial Distribution

  • D796114411 ()
  • D7961144 ()
  • D79611442 ()
  • D79611443 ()


  • Silicone dental impression material

MARK3 - D796114310

eXact VPS Impression Material Medium Fast Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1143
In Commercial Distribution

  • D796114310 ()
  • D7961143 ()
  • D79611432 ()
  • D79611433 ()


  • Silicone dental impression material

MARK3 - D79611421

eXact VPS Impression Material Medium Regular 50ml. Cartridges Set 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1142
In Commercial Distribution

  • D79611421 ()
  • D7961142 ()
  • D79611422 ()
  • D79611423 ()


  • Silicone dental impression material

MARK3 - D79611411

eXact VPS Impression Material Light Fast Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
1141
In Commercial Distribution

  • D79611411 ()
  • D7961141 ()
  • D79611412 ()
  • D79611413 ()


  • Silicone dental impression material

MARK3 - D79611401

eXact VPS Impression Material Light Regular Set 50ml. Cartridges 4/bx. - MARK3
CARGUS INTERNATIONAL, INC
11401
In Commercial Distribution

  • D79611401 ()
  • D7961140 ()
  • D79611402 ()
  • D79611403 ()


  • Silicone dental impression material

GLUSTITCH TWIST - D795G000150

No Description
Glustich Inc
GLTWI05C
Not in Commercial Distribution

  • D795G000151 ()
  • D795G000150 ()
  • D795G000152 ()


  • Skin-approximation adhesive

GluStitch® Twist - D795120

GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive. GluStitch Twist Tissue Adhesive is intended for the topical closure of surgical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch Twist may be used in conjunction with, but not in place of, deep dermal stitches.
Glustich Inc
GLTWI05C
In Commercial Distribution

  • D795122 ()
  • D795120 ()
  • D795121 ()
GLTWI05C

  • Skin-approximation adhesive

GluStitch® Twist - D795110

GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive. GluStitch Twist Tissue Adhesive is intended for the topical closure of surgical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch Twist may be used in conjunction with, but not in place of, deep dermal stitches.
Glustich Inc
GLTWI05
In Commercial Distribution

  • D795112 ()
  • D795110 ()
  • D795111 ()
GLTWI05

  • Skin-approximation adhesive
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