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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5 Panel Drug Test Cup AMP/COC/OPI/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-154
In Commercial Distribution

  • 20817038021273 ()
  • 10817038021276 ()
  • 00817038021279 ()
U-CUP-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 panel Test Card AMP/BZO/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-DOA-264L
In Commercial Distribution

  • 20817038021150 ()
  • 10817038021153 ()
  • 00817038021156 ()
U-DOA-264L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-CUP-254
In Commercial Distribution

  • 20817038021112 ()
  • 10817038021115 ()
  • 00817038021118 ()
U-CUP-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel OralTox - AMP/COC/MET/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80701
Not in Commercial Distribution

  • B313OT807011 ()
  • B313OT807010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Vaginal Verification Panel
MICROBIOLOGICS INC.
8208
In Commercial Distribution

  • 70845357041318 ()
8208

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Gram Positive Identification Panel
MICROBIOLOGICS INC.
5248P
In Commercial Distribution

  • 70845357039940 ()
5248P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: KWIK-STIK™ Gram Negative Identification Panel
MICROBIOLOGICS INC.
5247P
In Commercial Distribution

  • 70845357039933 ()
5247P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel
MICROBIOLOGICS INC.
ABT-001
In Commercial Distribution

  • 80845357043708 ()
ABT-001

  • SARS-CoV-2 nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Vaginal Control Panel
MICROBIOLOGICS INC.
8209
In Commercial Distribution

  • 70845357041325 ()
8209

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
Drugs of Abuse Dip Cards 12 DRUG PANEL WITH ADULTERANTS
MCKESSON MEDICAL-SURGICAL INC.
16-DTDC12P
In Commercial Distribution

  • 20612479255337 ()
  • 10612479255323 ()
  • 40612479255348 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Dip Cards 10 DRUG PANEL WITH ADULTERANTS
MCKESSON MEDICAL-SURGICAL INC.
16-DTDC10P
In Commercial Distribution

  • 20612479255306 ()
  • 10612479255293 ()
  • 40612479255317 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-6125A3
In Commercial Distribution

  • 20816490022484 ()
  • 10816490022487 ()
  • 00816490022480 ()
HDOA-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-4104A3
In Commercial Distribution

  • 20816490021647 ()
  • 10816490021640 ()
  • 00816490021643 ()
HDOA-4104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-1124A3
In Commercial Distribution

  • 20816490021098 ()
  • 10816490021091 ()
  • 00816490021094 ()
HDOA-1124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-654A3
In Commercial Distribution

  • 20816490020497 ()
  • 10816490020490 ()
  • 00816490020493 ()
HDOA-654A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-254A3
In Commercial Distribution

  • 20816490020435 ()
  • 10816490020438 ()
  • 00816490020431 ()
HDOA-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-154A3
In Commercial Distribution

  • 20816490020411 ()
  • 10816490020414 ()
  • 00816490020417 ()
HDOA-154A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-1104A3
In Commercial Distribution

  • 20816490021883 ()
  • 10816490021886 ()
  • 00816490021889 ()
HDOA-4104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-7104A3
In Commercial Distribution

  • 20816490021548 ()
  • 10816490021541 ()
  • 00816490021544 ()
HDOA-7104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-6124A3
In Commercial Distribution

  • 20816490020671 ()
  • 10816490020674 ()
  • 00816490020677 ()
HDOA-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000
Instant Technologies, Inc.
ABTDOAW14701A
In Commercial Distribution

  • 30817405023319 ()
  • 00817405023318 ()
  • 10817405023315 ()
ABTDOAW14701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET500-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
60740-6
In Commercial Distribution

  • B29860740610 ()
60740-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-COC-MET500-OPI300-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
60613-6
In Commercial Distribution

  • B29860613610 ()
60613-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Dip Drug Test, AMP-BARB-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
31106-6
In Commercial Distribution

  • B2983110660 ()
31106-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BARB-BZO-COC-MET500-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
30908-6
In Commercial Distribution

  • B2983090860 ()
30908-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Inspiration Ventilator System, model 7i Flagship with 17" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000103US0 ()
F7300000-7i-F-US

  • General-purpose intensive-care ventilator
Mylar Clad Cartridge Tube for Desk, Panel & Wall Unit 33
W. A. BAUM CO., INC.
2300
In Commercial Distribution

  • 00810010923547 ()
2300

  • Aneroid manual sphygmomanometer
The Dual M5 without Control with two Flat Panel Control, with two Flat Panel Monitors is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165741 ()
LM03N

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The FCR PRIMA II (CR-IR 391RU) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 391RU
In Commercial Distribution

  • 04547410189988 ()


  • Computed radiography digital imaging scanner
The Cradle is used for storing the fl at panel sensor in a standing position. By using in combination with the CALNEO C power supply unit or the AC adapter for cradle (optional), the battery pack for the fl at panel sensor inserted into the Cradle can be charged. In addition, when the Cradle is connected to the CALNEO C power supply unit, the wireless communication setting can be switched.
FUJIFILM CORPORATION
DR600 STAND E
In Commercial Distribution

  • 04547410180282 ()


  • Stationary basic diagnostic x-ray system, digital
A battery charger for the battery pack. Three packs can be charged at the same time.
FUJIFILM CORPORATION
DR601 SE BATTERY CHARGER E
In Commercial Distribution

  • 04547410180220 ()


  • Stationary basic diagnostic x-ray system, digital
A battery pack for the flat panel sensor (DR-ID 601SE, DR-ID 602SE and DR-ID 611SE) used in wireless communication mode.
FUJIFILM CORPORATION
DR601 SE BATTERY E
In Commercial Distribution

  • 04547410180213 ()


  • Stationary basic diagnostic x-ray system, digital
A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 600 MC E
In Commercial Distribution

  • 04547410134551 ()


  • Stationary basic diagnostic x-ray system, digital
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 15X30
In Commercial Distribution

  • 14547410049562 ()
  • 04547410049565 ()

  • 15X30 CM


  • Computed radiography digital imaging scanner
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 18X24cm
In Commercial Distribution

  • 14547410049555 ()
  • 04547410049558 ()

  • 18X24 CM


  • Computed radiography digital imaging scanner
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 24X30cm
In Commercial Distribution

  • 14547410049548 ()
  • 04547410049541 ()

  • 24X30 CM


  • Computed radiography digital imaging scanner
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 20.1X25.2cm(8X10)
In Commercial Distribution

  • 14547410049531 ()
  • 04547410049534 ()

  • 20.1X25.2 CM


  • Computed radiography digital imaging scanner
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 25.2X30.3cm(10X12)
In Commercial Distribution

  • 14547410049524 ()
  • 04547410049527 ()

  • 25.2X30.3 CM


  • Computed radiography digital imaging scanner
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 35.4X35.4cm(14X14)
In Commercial Distribution

  • 14547410049517 ()
  • 04547410049510 ()

  • 35.4X35.4 CM


  • Computed radiography digital imaging scanner
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 35.4X43.0cm(14X17)
In Commercial Distribution

  • 14547410049500 ()
  • 04547410049503 ()

  • 35.4X43.0 CM


  • Computed radiography digital imaging scanner
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