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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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XO Cross 35 - B090C35175H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-175-H
In Commercial Distribution

  • B090C35175H1 ()
  • B090C35175H0 ()
  • B090C35175H2 ()

  • Catheter Gauge: 3.9 French
  • Crossing Profile: 3.2 French
  • Catheter Working Length: 175 Centimeter
  • Introducer Sheath Compatibility: 4 French
C35-175-H

  • Vascular guide-catheter, single-use

XO Cross 35 - B090C35135H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135-H
In Commercial Distribution

  • B090C35135H1 ()
  • B090C35135H0 ()
  • B090C35135H2 ()

  • Catheter Gauge: 3.9 French
  • Crossing Profile: 3.2 French
  • Catheter Working Length: 135 Centimeter
  • Introducer Sheath Compatibility: 4 French
C35-135-H

  • Vascular guide-catheter, single-use

XO Cross 35 - B090C351350

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135
In Commercial Distribution

  • B090C351351 ()
  • B090C351350 ()
  • B090C351352 ()

  • Catheter Gauge: 3.9 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 3.2 French
  • Introducer Sheath Compatibility: 4 French
C35-135

  • Vascular guide-catheter, single-use

XO Cross 35 - B090C35090H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-090-H
In Commercial Distribution

  • B090C35090H1 ()
  • B090C35090H0 ()
  • B090C35090H2 ()

  • Catheter Gauge: 3.9 French
  • Catheter Working Length: 90 Centimeter
  • Introducer Sheath Compatibility: 4 French
  • Crossing Profile: 3.2 French
C35-090-H

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C14175H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-175-H
In Commercial Distribution

  • B090C14175H1 ()
  • B090C14175H0 ()
  • B090C14175H2 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 175 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-175-H

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C141750

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-175
In Commercial Distribution

  • B090C141751 ()
  • B090C141750 ()
  • B090C141752 ()

  • Catheter Gauge: 2 French
  • Introducer Sheath Compatibility: 2.9 French
  • Catheter Working Length: 175 Centimeter
  • Crossing Profile: 1.6 French
C14-175

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C14135H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-135-H
In Commercial Distribution

  • B090C14135H1 ()
  • B090C14135H0 ()
  • B090C14135H2 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-135-H

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C141350

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-135
In Commercial Distribution

  • B090C141351 ()
  • B090C141350 ()
  • B090C141352 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-135

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C14090H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-090-H
In Commercial Distribution

  • B090C14090H1 ()
  • B090C14090H0 ()
  • B090C14090H2 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 90 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-090-H

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C140900

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-090
In Commercial Distribution

  • B090C140901 ()
  • B090C140900 ()
  • B090C140902 ()

  • Catheter Working Length: 90 Centimeter
  • Crossing Profile: 1.6 French
  • Catheter Gauge: 2 French
  • Introducer Sheath Compatibility: 2.9 French
C14-090

  • Vascular guide-catheter, single-use

Control 10T Mechanical Thrombectomy System Tubing, Female Suction - B090ASP10400

The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1040
In Commercial Distribution

  • B090ASP10401 ()
  • B090ASP10400 ()
  • B090ASP10402 ()
ASP-1040

  • Thrombectomy tubing set, non-electronic

Control 10T Mechanical Thrombectomy Filter - B090ASP10390

The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy Filter is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1039
In Commercial Distribution

  • B090ASP10391 ()
  • B090ASP10390 ()
  • B090ASP10392 ()
ASP-1039

  • Thrombectomy tubing set, non-electronic

Control 11F Mechanical Thrombectomy System - B090ASP10360

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1036
In Commercial Distribution

  • B090ASP10361 ()
  • B090ASP10360 ()
  • B090ASP10362 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 11 French
ASP-1036

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control 7F Mechanical Thrombectomy System - B090ASP10330

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1033
In Commercial Distribution

  • B090ASP10331 ()
  • B090ASP10330 ()
  • B090ASP10332 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 7 French
ASP-1033

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control Mechanical Aspirator 30ml - B090ASP10290

The CONTROL MECHANICAL ASPIRATOR is intended to aspirate fluids from the body
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1029
In Commercial Distribution

  • B090ASP10291 ()
  • B090ASP10290 ()
  • B090ASP10292 ()
ASP-1029

  • General-purpose syringe, single-use

Control 11F Mechanical Thrombectomy System - B090ASP10210

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1021
In Commercial Distribution

  • B090ASP10211 ()
  • B090ASP10210 ()
  • B090ASP10212 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 11 French
ASP-1021

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control 7F Mechanical Thrombectomy System - B090ASP10130

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1013
In Commercial Distribution

  • B090ASP10131 ()
  • B090ASP10130 ()
  • B090ASP10132 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 7 French
ASP-1013

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control RX-LP Mechanical Thrombectomy System - B090ASP10010

The Control RX-LP6 Mechanical Thrombectomy Catheter™ and the Control Medical Mechanical Aspirator™ are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1001
In Commercial Distribution

  • B090ASP10011 ()
  • B090ASP10010 ()
  • B090ASP10012 ()

  • Catheter Gauge: 6 French
  • Catheter Length: 136 Centimeter
ASP-1001

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control 9F Mechanical Thrombectomy System, 90cm - B090A90900

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A9-090
In Commercial Distribution

  • B090A90901 ()
  • B090A90900 ()
  • B090A90902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 9 French
A9-090

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control 9F Mechanical Thrombectomy System, 60cm - B090A90600

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A9-060
In Commercial Distribution

  • B090A90601 ()
  • B090A90600 ()
  • B090A90602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 9 French
A9-060

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control 7F Mechanical Thrombectomy System - B090A70900

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A7-090
In Commercial Distribution

  • B090A70901 ()
  • B090A70900 ()
  • B090A70902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 7 French
A7-090

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control 7F Mechanical Thrombectomy System - B090A70600

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A7-060
In Commercial Distribution

  • B090A70600 ()
  • B090A70601 ()
  • B090A70602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 7 French
A7-060

  • Thrombectomy suction catheter
  • General-purpose syringe, single-use

Control 11F Mechanical Thrombectomy System - B090A110900

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A11-090
In Commercial Distribution

  • B090A110901 ()
  • B090A110900 ()
  • B090A110902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 11 French
A11-090

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control 11F Mechanical Thrombectomy System, 60cm - B090A110600

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A11-060
In Commercial Distribution

  • B090A110601 ()
  • B090A110600 ()
  • B090A110602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 11 French
A11-060

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

SPINR - B0905XGW0

Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
5X-GW
In Commercial Distribution

  • B0905XGW1 ()
  • B0905XGW0 ()
  • B0905XGW2 ()
5X-GW

  • Torque manipulation device

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

InTray® PDA - B08812930

Recommended by the American Public Health Association for plate counts of yeasts and molds in the examination of foods and dairy products, it is also used for maintenance, cultivation and sporulation of stock cultures of various dermatophytes and for differentiation of atypical varieties of dermatophytes by pigment production.
BIO-MED DIAGNOSTICS, INC.
1293
In Commercial Distribution

  • B08812934 ()
  • B08812930 ()
  • B08812932 ()
21-293-001

  • Potato-dextrose fungal agar culture medium IVD

InTray® SAB - B08812630

A general-purpose medium for the cultivation of pathogenic and non-pathogenic fungi, including dermatophytes. The low pH (approximately 5.6) is favorable for growth of fungi, especially yeasts and dermatophytes. Sabouraud's Dextrose Agar (SAB) is slightly inhibitory to contaminating bacteria in clinical specimens.
BIO-MED DIAGNOSTICS, INC.
1263
In Commercial Distribution

  • B08812634 ()
  • B08812630 ()
  • B08812632 ()
21-263-001

  • Basic/simple nutrient agar culture medium IVD

InTray® COLOREX Salmonella - B08812230

A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.
BIO-MED DIAGNOSTICS, INC.
1223
In Commercial Distribution

  • B08812234 ()
  • B08812230 ()
  • B08812232 ()
21-223-001

  • Chromogenic Salmonella species agar culture medium IVD
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