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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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TissuGlu Surgical Adhesive
COHERA MEDICAL, INC.
TG100US
In Commercial Distribution

  • M690TG100US0 ()
  • M690TG100US3 ()
TG100US

  • Surgical internal adhesive/sealant, synthetic polymer
PEDI,MANOMETER,PEEP ATTACHED,14',SOFT
VENTLAB, LLC
AF2100MB-PWTS4
In Commercial Distribution

  • 20889483102135 ()
  • 10889483102138 ()

  • Total Volume: 1000 Milliliter


  • Pulmonary resuscitator, manual, single-use
INFANT AIRFLOW W/MANOMETER AND 2 MASKS
VENTLAB, LLC
AF3100MB-M01
In Commercial Distribution

  • 20889483085797 ()
  • 10889483085790 ()

  • Total Volume: 300 Milliliter


  • Pulmonary resuscitator, manual, single-use
E/T TUBE NO-CUFF 5.0mm 20FR
SUNMED, LLC
1-7330-50
In Commercial Distribution

  • 20889483040475 ()
  • 10889483040478 ()

  • Length: 245 Millimeter
  • Outer Diameter: 6.67 Millimeter
  • Lumen/Inner Diameter: 5 Millimeter


  • Basic endotracheal tube, single-use
Immunoassay for the detection of buprenorphine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7105
In Commercial Distribution

  • M90107RD71051 ()
  • M90107RD71050 ()

  • Length: 75 Millimeter
07RD7105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of oxycodone in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7100
In Commercial Distribution

  • M90107RD71001 ()
  • M90107RD71000 ()

  • Length: 75 Millimeter
07RD7100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / PCP
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-15
In Commercial Distribution

  • M90107RD7073151 ()
  • M90107RD7073150 ()

  • Length: 75 Millimeter
07RD7073-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / MTD / OPI / OXY / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-08
In Commercial Distribution

  • M90107RD7073081 ()
  • M90107RD7073080 ()

  • Length: 75 Millimeter
07RD7073-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-04
In Commercial Distribution

  • M90107RD7073041 ()
  • M90107RD7073040 ()

  • Length: 75 Millimeter
07RD7073-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-03
In Commercial Distribution

  • M90107RD7073031 ()
  • M90107RD7073030 ()

  • Length: 75 Millimeter
07RD7073-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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