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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Defibrillator ,MAIN, ACLS-4, 3/5 LEAD, GPS, AC, NO RAILS, DMST
Zoll Medical Corporation
50000010010024013
In Commercial Distribution

  • 00847946007355 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN, ACLS-4, 3/5 LEAD, GPS, AC, RAILS, DMST
Zoll Medical Corporation
50000010010024012
In Commercial Distribution

  • 00847946007348 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator
MAIN, AED-1, 12 LEAD, SPO2/SPCO/SPMET/ETCO2/NIBP, BT/GPS, PACE, AC, NO RAILS, DMST, REFURB
Zoll Medical Corporation
80011910020164013
In Commercial Distribution

  • 00847946024604 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator
MAIN, AED-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, VOICE, NO RAILS, DMST, REFURB
Zoll Medical Corporation
80011830020174013
In Commercial Distribution

  • 00847946024581 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator
MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS, PACE, DC, NO RAILS, DMST, REFURB
Zoll Medical Corporation
80011820020124013
In Commercial Distribution

  • 00847946024567 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator
MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, RAILS, VOICE, DMST, REFURB
Zoll Medical Corporation
80001730020174012
In Commercial Distribution

  • 00847946024536 ()

  • 5.75" x 13.1" x 10.5"


  • Rechargeable professional automated external defibrillator
Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1 in. x 1.25 in. and are single patient use only.
AMPCARE, LLC
50709ST
In Commercial Distribution

  • 10867786000214 ()
  • 00867786000217 ()
50709ST

  • Transcutaneous electrical stimulation electrode, single-use
Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1.5 in. x 1.75 in. and are single patient use only.
AMPCARE, LLC
50709LT
In Commercial Distribution

  • 00867786000200 ()
  • 10867786000207 ()
50709LT

  • Transcutaneous electrical stimulation electrode, single-use
4.0MM 50° ABLATOR
E Surgical, LLC
RB4050-01
In Commercial Distribution

  • 00850053927041 ()
RB4050-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
4.0MM 50° ASPIRATING ABLATOR
E Surgical, LLC
RB4050A-01
In Commercial Distribution

  • 10850053927031 ()
  • 00850053927034 ()
RB4050A-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
4.0MM 90° ABLATOR
E Surgical, LLC
RB4090-01
In Commercial Distribution

  • 10850053927024 ()
  • 00850053927027 ()
RB4090-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
4.0MM 90° ASPIRATING ABLATOR
E Surgical, LLC
RB4090A-01
In Commercial Distribution

  • 00850053927010 ()
  • 10850053927017 ()
RB4090A-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
No Description
HONSUN (NANTONG) CO.,LTD
LD-737
In Commercial Distribution

  • 01697038425005 ()
  • 11697038425002 ()


  • Automatic-inflation electronic sphygmomanometer, portable, finger
No Description
Drägerwerk AG & Co. KGaA
8403076
Not in Commercial Distribution

  • 04048675176565 ()


  • Straight/elbow breathing circuit connector, reusable
Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor
DOUBLE HEAD STETHOSCOPE PINK
Wenzhou Caretek Medical Device Co., Ltd.
143212
In Commercial Distribution

  • 06975871430376 ()


  • Mechanical external stethoscope
DOUBLE HEAD STETHOSCOPE PURPLE
Wenzhou Caretek Medical Device Co., Ltd.
143231
In Commercial Distribution

  • 06975871430369 ()


  • Mechanical external stethoscope
DOUBLE HEAD STETHOSCOPE YELLOW
Wenzhou Caretek Medical Device Co., Ltd.
143226
In Commercial Distribution

  • 06975871430352 ()


  • Mechanical external stethoscope
T-MAT E 50SH 18x24cm film
CARESTREAM HEALTH, INC.
T-MAT E
In Commercial Distribution

  • 60889978450947 ()
  • 40889978450943 ()
  • 00889978450945 ()
8450942

  • Dental x-ray film, screen
T-MAT E 100SH 12.7x30.5cm film
CARESTREAM HEALTH, INC.
T-MAT E
In Commercial Distribution

  • 60889975216775 ()
  • 40889975216771 ()
  • 00889975216773 ()
5216775

  • Dental x-ray film, screen
T-MAT E 100SH 15x30cm film
CARESTREAM HEALTH, INC.
T-MAT E
In Commercial Distribution

  • 60889975216744 ()
  • 40889975216740 ()
  • 00889975216742 ()
5216742

  • Dental x-ray film, screen
No Description
HONSUN (NANTONG) CO.,LTD
LD-737
In Commercial Distribution

  • 01697038425005 ()


  • Automatic-inflation electronic sphygmomanometer, portable, finger
No Description
Firstar Healthcare Company Limited (Guangzhou)
FS-103
In Commercial Distribution

  • 06942272610300 ()


  • Cardiopulmonary resuscitation mask, reusable
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
UNIDOS E
In Commercial Distribution

  • EPTWT100100 ()
T10010

  • Radiation electrometer
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
UNIDOS E
In Commercial Distribution

  • EPTWT100090 ()
T10009

  • Radiation electrometer
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
UNIDOS E
In Commercial Distribution

  • EPTWT100080 ()
T10008

  • Radiation electrometer
Track E ø 3,0 x 125 mm
Forestadent Bernhard Förster GmbH
1
In Commercial Distribution

  • EFOR4080530001 ()
  • EFOR4080530 ()
-408-0530

  • Dental appliance fabrication material, thermoplastic
Track E ø 2,0 x 125 mm
Forestadent Bernhard Förster GmbH
1
In Commercial Distribution

  • EFOR4080520001 ()
  • EFOR4080520 ()
-408-0520

  • Dental appliance fabrication material, thermoplastic
Track E ø 1,5 x 125 mm
Forestadent Bernhard Förster GmbH
1
In Commercial Distribution

  • EFOR4080515001 ()
  • EFOR4080515 ()
-408-0515

  • Dental appliance fabrication material, thermoplastic
No Description
HYCOR BIOMEDICAL LLC
K332065-2Z
In Commercial Distribution

  • 00816879029642 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332030-2Z
In Commercial Distribution

  • 00816879029635 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332020-2Z
In Commercial Distribution

  • 00816879029628 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63180Z
In Commercial Distribution

  • 00816879029550 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63125Z
In Commercial Distribution

  • 00816879029499 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K33218085-4Z
In Commercial Distribution

  • 00816879029468 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332065-2
In Commercial Distribution

  • 00816879028881 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K33218085-4
In Commercial Distribution

  • 00816879028850 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332030-2
In Commercial Distribution

  • 00816879028836 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332020-2
In Commercial Distribution

  • 00816879028829 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63125
In Commercial Distribution

  • 00816879023251 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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