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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12 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-3124
In Commercial Distribution

  • 20816490021463 ()
  • 10816490021466 ()
  • 00816490021469 ()
HCDOAV-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-7105
In Commercial Distribution

  • 20816490021456 ()
  • 10816490021459 ()
  • 00816490021452 ()
HCDOAV-7105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-474
In Commercial Distribution

  • 20816490021449 ()
  • 10816490021442 ()
  • 00816490021445 ()
HCDOAV-474

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-3104
In Commercial Distribution

  • 20816490021432 ()
  • 10816490021435 ()
  • 00816490021438 ()
HCDOAV-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-955
In Commercial Distribution

  • 20816490021418 ()
  • 10816490021411 ()
  • 00816490021414 ()
HCDOAV-955

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-154
In Commercial Distribution

  • 20816490021333 ()
  • 10816490021336 ()
  • 00816490021339 ()
HCDOAV-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-285TS
In Commercial Distribution

  • 20816490021272 ()
  • 10816490021275 ()
  • 00816490021278 ()
HCDOAV-285TS

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-654
In Commercial Distribution

  • 20816490021241 ()
  • 10816490021244 ()
  • 00816490021247 ()
HCDOAV-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51215
Not in Commercial Distribution

  • 81781502512158 ()
51215

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51205
Not in Commercial Distribution

  • 81781502512059 ()
51205

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51125
Not in Commercial Distribution

  • 81781502511250 ()
51125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51105
Not in Commercial Distribution

  • 81781502511052 ()
51105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51005
Not in Commercial Distribution

  • 81781502510055 ()
51005

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50915
Not in Commercial Distribution

  • 81781502509158 ()
50915

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50905
Not in Commercial Distribution

  • 81781502509059 ()
50905

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50715
Not in Commercial Distribution

  • 81781502507154 ()
50715

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, BAR-BZO-COC-MET-OPI-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50705
Not in Commercial Distribution

  • 81781502507055 ()
50705

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, COC-MET-OPI-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50505
Not in Commercial Distribution

  • 81781502505051 ()
50505

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BD MAX™ CT/GC/TV 20-Day QC Panel
MICROBIOLOGICS INC.
8193 BD MAX™ CT/GC/TV 20-Day QC Panel
Not in Commercial Distribution

  • 70845357041080 ()
8193

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Yeast Identification Panel
MICROBIOLOGICS INC.
5252P
In Commercial Distribution

  • 70845357040168 ()
5252P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: KWIK-STIK™ Anaerobe Identification Panel
MICROBIOLOGICS INC.
5246P
In Commercial Distribution

  • 70845357039926 ()
5246P

  • Multiple bacteria species culture isolate identification control IVD, kit
FIXED ARM SIDEFRAME & SIDE PANEL - LEFT - TRAVELER SE PLUS
GF HEALTH PRODUCTS, INC.
90763002A
In Commercial Distribution

  • M36890763002A1 ()
90763002A

  • Push-rim manual wheelchair, non-bariatric
FIXED ARM SIDEFRAME & SIDE PANEL - RIGHT - TRAVELER SE PLUS
GF HEALTH PRODUCTS, INC.
90763001A
In Commercial Distribution

  • M36890763001A1 ()
90763001A

  • Push-rim manual wheelchair, non-bariatric
Inspiration Ventilator System, model 7i with 12" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000102US0 ()
F7300000-7i-S-US

  • General-purpose intensive-care ventilator
Inspiration Ventilator System, model 7i with 17" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000101US0 ()
F7300000-7i-L-US

  • General-purpose intensive-care ventilator
Trumpf Medical/Medizin Operating panel for table top II
Baxter Medical Systems GmbH + Co. KG
1549939
Not in Commercial Distribution

  • 00887761988484 ()


  • Operating room equipment remote control
Sample Collection Kit, Blood (5 DBS), Food Sensitivity Panel
Cue Health Inc.
C2234
In Commercial Distribution

  • 00810040821103 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Dual), Women's Fertility Panel
Cue Health Inc.
C2227
In Commercial Distribution

  • 00810040821066 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Dual), Women's Health Panel
Cue Health Inc.
C2226
In Commercial Distribution

  • 00810040821059 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Single), Men's Health Panel
Cue Health Inc.
C2245
In Commercial Distribution

  • 00810040821011 ()


  • Capillary blood collection kit IVD
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