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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11 Panel Dip Drug Test, AMP-BAR-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
31125-3
Not in Commercial Distribution

  • B2983112530 ()
31125-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Dip Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-THC-pH,SG,OX
Express Diagnostic Int'l, Inc.
31105-3
In Commercial Distribution

  • B29831105310 ()
31105-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Dip Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
31105-3
Not in Commercial Distribution

  • B2983110530 ()
31105-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Drug Test, BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
31090-3
Not in Commercial Distribution

  • B2983109030 ()
31090-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
31045-3
Not in Commercial Distribution

  • B2983104530 ()
31045-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Drug Test, AMP-BAR-BZO-COC-MET-OPI-OXY-PCP-PPX-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
31014-3
Not in Commercial Distribution

  • B2983101430 ()
31014-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Drug Test, AMP-BARB-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC-pH,SG,OX
Express Diagnostic Int'l, Inc.
31011-3
In Commercial Distribution

  • B29831011310 ()
31011-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Drug Test, AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
31011-3
Not in Commercial Distribution

  • B2983101130 ()
31011-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
31005-3
Not in Commercial Distribution

  • B2983100530 ()
31005-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30903-3
Not in Commercial Distribution

  • B2983090330 ()
30903-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Dip Drug Test, AMP-BAR-BZO-COC-MET-OPI-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30802-3
Not in Commercial Distribution

  • B2983080230 ()
30802-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Dip Drug Test, AMP-COC-MET-OPI-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30630-3
Not in Commercial Distribution

  • B2983063030 ()
30630-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Dip Drug Test, AMP-BZO-COC-MET-OPI-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30600-3
Not in Commercial Distribution

  • B2983060030 ()
30600-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, BZO-COC-MET-OPI300-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30573-3
Not in Commercial Distribution

  • B2983057330 ()
30573-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, BZO-COC-MET-OPI-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30572-3
Not in Commercial Distribution

  • B2983057230 ()
30572-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel Dip Drug Test, AMP-COC-OPI300-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30401-3
Not in Commercial Distribution

  • B2983040130 ()
30401-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, AMP-COC-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30310-3
Not in Commercial Distribution

  • B2983031030 ()
30310-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, AMP-COC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30206-3
Not in Commercial Distribution

  • B2983020630 ()
30206-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80510
Not in Commercial Distribution

  • B313OT805101 ()
  • B313OT805100 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - AMP/COC/MET/OPI/THC
PREMIER BIOTECH, INC
OT80508
Not in Commercial Distribution

  • B313OT805081 ()
  • B313OT805080 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - AMP/COC/OPI/PCP/THC
PREMIER BIOTECH, INC
OT80504
Not in Commercial Distribution

  • B313OT805041 ()
  • B313OT805040 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - AMP/COC/MET/OPI/THC
PREMIER BIOTECH, INC
OT80502
Not in Commercial Distribution

  • B313OT805021 ()
  • B313OT805020 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Front Panel Without PCB, For Mega Power Generator
MEGADYNE MEDICAL PRODUCTS, INC.
6020169-01
Not in Commercial Distribution

  • 10614559103777 ()


  • Electrosurgical system generator
Front Panel With PCB, For Mega Power Generator
MEGADYNE MEDICAL PRODUCTS, INC.
6020094-01
Not in Commercial Distribution

  • 10614559103074 ()


  • Electrosurgical system generator
Front Panel Without PCB, For Mega Power Generator
MEGADYNE MEDICAL PRODUCTS, INC.
6020093-01
Not in Commercial Distribution

  • 10614559103067 ()


  • Electrosurgical system generator
11 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
Zerochaos
61113-3 ZC
Not in Commercial Distribution

  • B539611133ZC0 ()
61113-3 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
Zerochaos
61020-3 ZC
In Commercial Distribution

  • B539610203ZC10 ()
61020-3 ZC

  • 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
Zerochaos
61020-3 ZC
Not in Commercial Distribution

  • B539610203ZC0 ()
61020-3 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
Zerochaos
60967-3-ZC
In Commercial Distribution

  • B539609673ZC10 ()
60967-3-ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
Zerochaos
60967-3-ZC
Not in Commercial Distribution

  • B539609673ZC0 ()
60967-3-ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX
Zerochaos
60505-3 ZC
In Commercial Distribution

  • B539605053ZC10 ()
60505-3 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX
Zerochaos
60505-3 ZC
Not in Commercial Distribution

  • B539605053ZC0 ()
60505-3 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Hemorrhage View C-Section Drape, Sterile, full Inc Panel
EXACT MEDICAL MANUFACTURING, INC.
HemviewCSD1001S
In Commercial Distribution

  • 26975424196555 ()
  • 06975424196551 ()
HemviewCSD1001S

  • Patient surgical drape, single-use
Hemorrhage View C-Section Drape,Sterile, full incision panel
EXACT MEDICAL MANUFACTURING, INC.
HemviewCSD1001S
In Commercial Distribution

  • 26975424195251 ()
  • 06975424195257 ()
HemviewCSD1001S

  • Patient surgical drape, single-use
Sample Collection Kit, Blood (Adx Single), Kidney Panel
Cue Health Inc.
C2236
In Commercial Distribution

  • 00810040821004 ()


  • Capillary blood collection kit IVD
GOWN,SURG,XALT,L3,PANEL CVR,GREEN,XL
MEDLINE INDUSTRIES, INC.
MDTGXP3JXL
In Commercial Distribution

  • 30884389189218 ()
  • 10884389189214 ()
MDTGXP3JXL

  • Surgical gown, reusable
CVi bed mount control panel, p/n 700130-005
ACIST MEDICAL SYSTEMS, INC.
014607
In Commercial Distribution

  • 30841716101022 ()


  • Angiography contrast medium injection system, line-powered, mobile
Arctic Sun® 5000 Control Panel Screen Protector
Medivance, Inc.
75300
In Commercial Distribution

  • 00801741080470 ()
75300

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Sample Collection Kit, Blood (Adx Dual), Liver Panel
Cue Health Inc.
C2233
In Commercial Distribution

  • 00810040821080 ()


  • Capillary blood collection kit IVD
TR2810 US Shower panel with thermostatic mixer / Lock
Tr Equipment AB
0520072
In Commercial Distribution

  • 07350016061117 ()


  • Bathing/changing table, mobile
GOWN,SURG,XALT,L4,PANEL CVR,OBLUE,XL
MEDLINE INDUSTRIES, INC.
MDTAUSGXP4OXL
In Commercial Distribution

  • 20888277418179 ()
  • 10888277418172 ()
MDTAUSGXP4OXL

  • Surgical gown, reusable
GOWN,SURG,XALT,L4,PANEL CVR,OBLUE,L
MEDLINE INDUSTRIES, INC.
MDTAUSGXP4OL
In Commercial Distribution

  • 20888277418162 ()
  • 10888277418165 ()
MDTAUSGXP4OL

  • Surgical gown, reusable
GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L
MEDLINE INDUSTRIES, INC.
MDTGXP4JL
In Commercial Distribution

  • 40888277189219 ()
  • 10888277189218 ()
MDTGXP4JL

  • Surgical gown, reusable
GOWN,SURG,XALT,L3,PANEL CVR,GREEN,XX
MEDLINE INDUSTRIES, INC.
MDTGXP3JXXL
In Commercial Distribution

  • 40884389193304 ()
  • 10884389193303 ()
MDTGXP3JXXL

  • Surgical gown, reusable
GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL
MEDLINE INDUSTRIES, INC.
MDTGXP4JXL
In Commercial Distribution

  • 40884389189222 ()
  • 10884389189221 ()
MDTGXP4JXL

  • Surgical gown, reusable
Drugs of Abuse Test 10-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-8105A3
In Commercial Distribution

  • 40612479228823 ()
  • 20612479228812 ()
  • 10612479231013 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 14-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-1145A3
In Commercial Distribution

  • 40612479228809 ()
  • 20612479228799 ()
  • 10612479231006 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 12-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-6125A3
In Commercial Distribution

  • 40612479228786 ()
  • 20612479228775 ()
  • 10612479230993 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 12-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-5125A3
In Commercial Distribution

  • 40612479228762 ()
  • 20612479228751 ()
  • 10612479230986 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Cotinine (COT) Rapid Test Panel box of 40
Hangzhou AllTest Biotech Co., Ltd.
DCT-114
In Commercial Distribution

  • 06970277512527 ()
  • 06970277512510 ()
DCT-114

  • Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
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