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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I5 Printer clean side, includes mounting panel and cables
SKYTRON LLC
I5-PRCS
In Commercial Distribution

  • 10841736100513 ()
I5-PRCS

  • Surgical instrument washer/disinfector (chemical/thermal)
CVi Angiographic Injection System Control Panel, p/n 701557-001
ACIST MEDICAL SYSTEMS, INC.
017738
Not in Commercial Distribution

  • 10841716101196 ()


  • Angiography contrast medium injection system, line-powered, mobile
CVi Angiographic Injection System Control Panel, p/n 700771-005
ACIST MEDICAL SYSTEMS, INC.
017738
Not in Commercial Distribution

  • 30841716100629 ()
  • 10841716100625 ()


  • Angiography contrast medium injection system, line-powered, mobile
mLife Verify 9 panel oral fluid drug test AMP-COC-MET-OPI-THC-FEN-MDMA-OXY-PCP
Mlife Diagnostics, LLC
MV002.09.0001EI
In Commercial Distribution

  • G474MV002090001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 6 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
MV002.06.0001EI
In Commercial Distribution

  • G474MV002060001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MV001.10.0003EI
In Commercial Distribution

  • G474MV001100003EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 9 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC-6MAM-MDMA-OXY
Mlife Diagnostics, LLC
MV001.09.0003EI
In Commercial Distribution

  • G474MV001090003EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 9 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-THC
Mlife Diagnostics, LLC
MV001.09.0002-EI
In Commercial Distribution

  • G474MV001090002EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 9 panel oral fluid drug test AMP-COC-MDMA-THC-MET-OPI-OXY-PCP-FEN
Mlife Diagnostics, LLC
MV001.09.0001-EI
In Commercial Distribution

  • G474MV001090001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 8 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC-MDMA-OXY
Mlife Diagnostics, LLC
MV001.08.0001EI
In Commercial Distribution

  • G474MV001080001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 6 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
MV001.06.0001-EI
In Commercial Distribution

  • G474MV001060001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP
Mlife Diagnostics, LLC
MV001.05.0001-EI
In Commercial Distribution

  • G474MV001050001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 11 panel oral fluid drug test AMP-BAR-BZO-COC-FYL-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MC002.11.0001EI
In Commercial Distribution

  • G474MC002110001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MC002.10.0001EI
In Commercial Distribution

  • G474MC002100001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 8 Panel Oral Fluid Drug Test AMP-COC-MET-OPI-OXY-BAR-BZO-MDMA
Mlife Diagnostics, LLC
MC002.08.0001EI
In Commercial Distribution

  • G474MC002080001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MC001.10.0001-EI
In Commercial Distribution

  • G474MC001100001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 6 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
MC001.06.0001-EI
In Commercial Distribution

  • G474MC001060001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-THC
Mlife Diagnostics, LLC
MC001.05.0002EI
In Commercial Distribution

  • G474MC001050002EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP
Mlife Diagnostics, LLC
MC001.05.0001-EI
In Commercial Distribution

  • G474MC001050001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 6 Panel Oral Fluid Drug Test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
M310601
In Commercial Distribution

  • G474M3106010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP
Mlife Diagnostics, LLC
M310501
In Commercial Distribution

  • G474M3105010 ()


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