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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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Knight Microcatheter - B0902P0130B0

The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-B
In Commercial Distribution

  • B0902P0130B1 ()
  • B0902P0130B0 ()
  • B0902P0130B2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
2P0-130-B

  • Vascular microcatheter

InTray® Mueller Hinton Chocolate Agar - B08824830

Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C.
BIO-MED DIAGNOSTICS, INC.
2483
In Commercial Distribution

  • B08824834 ()
  • B08824830 ()
  • B08824832 ()
22-483-001

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD

InTray® DM - B08820630

An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.
BIO-MED DIAGNOSTICS, INC.
2063
In Commercial Distribution

  • B08820630 ()
  • B08820634 ()
  • B08820632 ()
22-063-000

  • Multiple dermatophyte species culture isolate identification IVD, kit

Saline Solution (0.85%) - B08816120

Saline Solution (0.85%) is a saline solution for viral specimens.
BIO-MED DIAGNOSTICS, INC.
1612
In Commercial Distribution

  • B08816120 ()
  • B08816121 ()
  • B08816122 ()
11-612-001

  • Saline suspension medium/diluent IVD

VTM-C19 Transit Tube - B08816020

The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided), transported appropriately to the lab and analyzed with validated qRT-PCR assays for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans. Manufacturers Note: Under enforcement discretion, we are currently exempt of having 510(k) during emergency and threat of Covid.
BIO-MED DIAGNOSTICS, INC.
1602
In Commercial Distribution

  • B08816026 ()
  • B08816020 ()
  • B08816021 ()
11-602-001

  • Viral transport medium IVD

InTray DM-FungID - B08815930

InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota.
BIO-MED DIAGNOSTICS, INC.
1593
In Commercial Distribution

  • B08815934 ()
  • B08815930 ()
  • B08815932 ()
21-593-001

  • Multiple dermatophyte species culture isolate identification IVD, kit

InTray® BHI - B08815030

Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds.
BIO-MED DIAGNOSTICS, INC.
1503
In Commercial Distribution

  • B08815034 ()
  • B08815030 ()
  • B08815032 ()
21-503-001

  • Basic/simple nutrient agar culture medium IVD

InTray® XLT4 - B08814930

A medium devised for selection of non-typhi Salmonella from samples contaminated with fecal matter. Growth of other organisms is inhibited and Salmonella can be differentiated from other organisms by colony color.
BIO-MED DIAGNOSTICS, INC.
1493
In Commercial Distribution

  • B08814934 ()
  • B08814930 ()
  • B08814932 ()
21-493-001

  • Salmonella/Shigella species agar culture medium IVD

InTray® Brilliant Green - B08814630

Highly selective medium for the isolation of Salmonella other than S. typhi from feces and other materials.
BIO-MED DIAGNOSTICS, INC.
1463
In Commercial Distribution

  • B08814634 ()
  • B08814630 ()
  • B08814632 ()
21-463-001

  • MLCB Salmonella species agar culture medium IVD

InTray® TSA - B08814430

A non-selective medium used for isolation, cultivation and enumeration of non-fastidious and fastidious microorganisms. The device is designed to interface directly with standard methods for bacterial testing of water samples using the Membrane Filter (MF) Technique.
BIO-MED DIAGNOSTICS, INC.
1443
In Commercial Distribution

  • B08814434 ()
  • B08814430 ()
  • B08814432 ()
21-443-001

  • Basic/simple nutrient agar culture medium IVD

InTray® SMA - B08814230

a selective and differential media for the detection of sorbitol-non-fermenting Escherichia coli serotype O157:H7 associated with hemorrhagic colitis. This medium is also referred to as "MacConkey Sorbitol Agar."
BIO-MED DIAGNOSTICS, INC.
1423
In Commercial Distribution

  • B08814234 ()
  • B08814230 ()
  • B08814232 ()
21-423-001

  • Sorbitol-MacConkey E. coli agar culture medium IVD

InTray® Malt Extract Agar - B08813330

A nutrient-rich medium for the use of cultivation, isolation and enumeration of a broad-spectrum of environmental and pathogenic yeasts and molds. The device can accept samples by direct plating or interface directly with standard methods for microbial testing of water samples using the Membrane Filter (MF) Technique1. The acidic pH of Malt Extract Agar allows for the optimal growth of molds and yeasts while restricting bacterial growth.
BIO-MED DIAGNOSTICS, INC.
1333
In Commercial Distribution

  • B08813334 ()
  • B08813330 ()
  • B08813332 ()
21-333-001

  • Malt extract agar culture medium IVD

InTray® MSA - B08813030

Mannitol Salt Agar (MSA) test uses a selective isolation media for the enumeration of staphylococci from clinical/non-clinical materials. A change of the phenol red indicator (Mannitol fermentation) aids in differentiating staphylococci species.
BIO-MED DIAGNOSTICS, INC.
1303
In Commercial Distribution

  • B08813034 ()
  • B08813030 ()
  • B08813032 ()
21-303-001

  • Mannitol-salt Staphylococcus species agar culture medium IVD

InPouch® TV - B08810310

Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution

  • B08810310 ()
  • B08810317 ()
  • B08810313 ()
21-031-001

  • Differential/selective broth culture medium IVD

U400 ImpSoft Software - B277292U400CD0

Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution

  • B277292U400CD2 ()
  • B277292U400CD1 ()
  • B277292U400CD0 ()
292-U400CD

  • Bioelectrical body composition analyser

Body Composition Analysis Software - B277292DF50CD0

DF50 Body Composition Analysis Software
IMPEDIMED LIMITED
4.1.2
Not in Commercial Distribution

  • B277292DF50CD1 ()
  • B277292DF50CD0 ()
  • B277292DF50CD2 ()
292-DF50CD

  • Bioelectrical body composition analyser

SOZO Body Fluid Analyzer - B27727270000

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor.
IMPEDIMED LIMITED
2727000
In Commercial Distribution

  • B27727270000 ()
  • B27727270001 ()
  • B27727270002 ()
2727000

  • Bioelectrical body composition analyser

SOZO Body Fluid Analyzer - B27727269950

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor.
IMPEDIMED LIMITED
2727000
In Commercial Distribution

  • B27727269950 ()
  • B27727269951 ()
  • B27727269952 ()
2727000

  • Bioelectrical body composition analyser

Imp SFB7 - B277259SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. ROW Demo-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277259SFB72 ()
  • B277259SFB71 ()
  • B277259SFB70 ()
259-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277259DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. ROW Demo Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277259DF502 ()
  • B277259DF500 ()
  • B277259DF501 ()
229-DF50

  • Bioelectrical body composition analyser

Imp SFB7 - B277253SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. US Demo-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277253SBF72 ()
  • B277253SBF71 ()
  • B277253SFB70 ()
253-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277253DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. US Demo Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277253DF502 ()
  • B277253DF501 ()
  • B277253DF500 ()
229-DF50

  • Bioelectrical body composition analyser

L-Dex® U400 - B277252LDEXU4000

BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. Demo Device
IMPEDIMED LIMITED
U400
In Commercial Distribution

  • B227252LDEXU4002 ()
  • B277252LDEXU4001 ()
  • B277252LDEXU4000 ()
242-LDEXU400

  • Bioelectrical body composition analyser

SOZO Body Fluid Analyzer - B27725269950

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. Demo Device
IMPEDIMED LIMITED
2526995
In Commercial Distribution

  • B27725269950 ()
  • B27725269951 ()
  • B27725269952 ()
252-SOZO

  • Bioelectrical body composition analyser

Imp SFB7 - B277249SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. ROW Refurbished-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277249SFB70 ()
  • B277249SFB71 ()
  • B277249SFB72 ()


  • Bioelectrical body composition analyser

Imp DF50 - B277249DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. ROW Refurbished Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277249DF502 ()
  • B277249DF501 ()
  • B277249DF500 ()
229-DF50

  • Bioelectrical body composition analyser

Imp SFB7 - B277243SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. US Refurbished- Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277243SFB72 ()
  • B277243SBF71 ()
  • B277243SFB70 ()
243-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277243DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. US Refurbished Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277243DF502 ()
  • B277243DF501 ()
  • B277243DF500 ()
229-DF50

  • Bioelectrical body composition analyser

L-Dex® U400 - B277242LDEXU4000

BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. Refurbished Device
IMPEDIMED LIMITED
U400
In Commercial Distribution

  • B277242LDEXU4002 ()
  • B277242LDEXU4001 ()
  • B277242LDEXU4000 ()
242-LDEXU400

  • Bioelectrical body composition analyser

SOZO Body Fluid Analyzer - B27724269950

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. Refurbished Device
IMPEDIMED LIMITED
2426995
In Commercial Distribution

  • B27724269952 ()
  • B27724269951 ()
  • B27724269950 ()
242-SOZO

  • Bioelectrical body composition analyser

Imp SFB7 - B277229SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. ROW New-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277229SFB72 ()
  • B277229SFB71 ()
  • B277229SFB70 ()
229-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277229DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. ROW New Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277229DF502 ()
  • B277229DF501 ()
  • B277229DF500 ()
229-DF50

  • Bioelectrical body composition analyser

Imp SFB7 - B277223SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. US New-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277223SFB72 ()
  • B277223SFB71 ()
  • B277223SFB70 ()
223-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277223DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. US New Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277223DF502 ()
  • B277223DF501 ()
  • B277223DF500 ()
223-DF50

  • Bioelectrical body composition analyser

L-Dex® U400 - B277222LDEXU4000

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. New-Device
IMPEDIMED LIMITED
U400
In Commercial Distribution

  • B277222LDEXU4002 ()
  • B277222LDEXU4001 ()
  • B277222LDEXU4000 ()
222-LDEXU400

  • Bioelectrical body composition analyser

Ostial Sprit Cannulae - B270CVCP040080

Ostial Perfusion Cannula
Spyder Medical
CV.CP04008
In Commercial Distribution

  • B270CVCP040082 ()
  • B270CVCP040080 ()
  • B270CVCP040081 ()
CV.CP04008

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP040070

Ostial Perfusion Cannula
Spyder Medical
CV.CP04007
In Commercial Distribution

  • B270CVCP040072 ()
  • B270CVCP040070 ()
  • B270CVCP040071 ()
CV.CP04007

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP040060

Ostial Perfusion Cannula
Spyder Medical
CV.CP04006
In Commercial Distribution

  • B270CVCP040062 ()
  • B270CVCP040060 ()
  • B270CVCP040061 ()
CV.CP4006

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP040050

Ostial Perfusion Cannula
Spyder Medical
CV.CP04005
In Commercial Distribution

  • B270CVCP040052 ()
  • B270CVCP040050 ()
  • B270CVCP040051 ()
CV.CP04005

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP040040

Ostial Perfusion Cannula
Spyder Medical
CV.CP04004
In Commercial Distribution

  • B270CVCP040042 ()
  • B270CVCP040040 ()
  • B270CVCP040041 ()
CV.CP04004

  • Vascular irrigation cannula, coronary artery, single-use
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