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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 - B0902P0130S0

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-S
In Commercial Distribution

  • B0902P0130S1 ()
  • B0902P0130S0 ()
  • B0902P0130S2 ()

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

  • Vascular microcatheter

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® 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® 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

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

CosmoLock Pedicle Screw System - B07311LCL00000

Locking Cap
Kalitec Direct LLC
11-LCL-0000
In Commercial Distribution

  • B07311LCL00000 ()
  • B07311LCL00002 ()
  • B07311LCL00001 ()


  • Spinal bone set screw

Cryolock - B056CLRCT1

Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT
Not in Commercial Distribution

  • B056CLRCT2 ()
  • B056CLRCT1 ()
  • B056CLRCT0 ()
  • B056CLRCT5 ()
CL-R-CT

  • Assisted reproduction vitrification carrier

O-Mask Oxygen Mask, Child - B00262100

O-Mask Oxygen Mask, Child
B.L.S. Systems Limited
6210
In Commercial Distribution

  • B00262107 ()
  • B00262100 ()
  • B00262109 ()

  • Child
6210

  • Non-rebreathing oxygen face mask

Rescuer Flo2Max Oxygen Mask, Large Adult - B0026100U0

Rescuer Flo2Max Oxygen Mask with Universal Tubing, Large Adult
B.L.S. Systems Limited
6100
In Commercial Distribution

  • B0026100U7 ()
  • B0026100U0 ()
  • B0026100U9 ()

  • Large Adult
6100-U

  • Non-rebreathing oxygen face mask

Rescuer BVM Manual Resuscitator - B00240500

Rescuer disposable adult manual resuscitator with pressure release valve, 2900 mL reservoir, #5 cushion mask and 2 m crush proof oxygen tubing
B.L.S. Systems Limited
4050
In Commercial Distribution

  • B00240506 ()
  • B00240500 ()
  • B00240501 ()

  • Adult
4050

  • Pulmonary resuscitator, manual, single-use

Rescuer BVM Manual Resuscitator - B00240250

Rescuer disposable infant manual resuscitator with 800 mL reservoir, #1 cushion mask and 2 m crush proof oxygen tubing.
B.L.S. Systems Limited
4025
In Commercial Distribution

  • B00240256 ()
  • B00240250 ()
  • B00240251 ()

  • Infant
4025

  • Pulmonary resuscitator, manual, single-use

Rescuer BVM Manual Resuscitator - B00240100

Rescuer Child Size manual resuscitator with 2900 mL reservoir, #3 cushion mask and 2 m crush proof oxygen tubing (each)
B.L.S. Systems Limited
4010
In Commercial Distribution

  • B00240100 ()
  • B00240106 ()
  • B00240101 ()

  • Child
4010

  • Pulmonary resuscitator, manual, single-use

Disposable PEEP Valve - B0024000PEEP0

Disposable PEEP valve for use on the Rescuer manual resuscitator.
B.L.S. Systems Limited
4000-PEEP
In Commercial Distribution

  • B0024000PEEP3 ()
  • B0024000PEEP0 ()
  • B0024000PEEP2 ()
4000-PEEP

  • PEEP valve, single-use

Rescuer - B0024000F0

HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator)
B.L.S. Systems Limited
4000F
In Commercial Distribution

  • B0024000F0 ()
  • B0024000F2 ()
  • B0024000F3 ()
4000F

  • Microbial medical gas filter, single-use

Rescuer BVM Manual Resuscitator - B00240000

Rescuer adult disposable manual resuscitator with 2900 mL reservoir bag, #5 cushion mask and 2 m crush proof oxygen tubing (Single Unit)
B.L.S. Systems Limited
4000
In Commercial Distribution

  • B00240000 ()
  • B00240006 ()
  • B00240001 ()

  • Adult
4000

  • Pulmonary resuscitator, manual, single-use

Rescuer 7000-AD Replacement Suction Canister kit - B0027000AD0

Replacement canister kit and catheters for 7000-MVP
B.L.S. Systems Limited
7000-AD
In Commercial Distribution

  • B0027000AD9 ()
  • B0027000AD0 ()
  • B0027000AD2 ()
7000-AD

  • Emergency airway clearance suction pump, manual

Rescuer O-Mask Oxygen Mask with Universal Tubing - B0026210U0

Rescuer O-Mask Oxygen Mask with Universal Tubing (Child)
B.L.S. Systems Limited
6210-U
In Commercial Distribution

  • B0026210U7 ()
  • B0026210U0 ()
  • B0026210U9 ()

  • Child
6210-U

  • Non-rebreathing oxygen face mask

Rescuer O-Mask with Universal Oxygen Tubing (Small Adult) - B0026205U0

Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)
B.L.S. Systems Limited
6205-U
In Commercial Distribution

  • B0026205U7 ()
  • B0026205U0 ()
  • B0026205U9 ()

  • Small Adult
6205-U

  • Non-rebreathing oxygen face mask

O-Mask Oxygen Mask, Small Adult - B00262050

O-Mask Oxygen Mask, Small Adult
B.L.S. Systems Limited
6205
In Commercial Distribution

  • B00262057 ()
  • B00262050 ()
  • B00262059 ()

  • Small Adult
6205

  • Non-rebreathing oxygen face mask

Rescuer O-Mask - B0026200U0

Rescuer O-Mask with Universal Tubing (Large Adult)
B.L.S. Systems Limited
6200-U
In Commercial Distribution

  • B0026200U0 ()
  • B0026200U7 ()
  • B0026200U9 ()

  • Large Adult
6200-U

  • Non-rebreathing oxygen face mask

O-Mask Oxygen Mask, Large Adult - B00262000

O-Mask Oxygen Mask, Large Adult
B.L.S. Systems Limited
6200
In Commercial Distribution

  • B00262007 ()
  • B00262000 ()
  • B00262009 ()

  • Large Adult
6200

  • Non-rebreathing oxygen face mask

Rescuer Flo2Max Oxygen Mask, Child - B0026110U0

Rescuer Flo2Max Oxygen Mask with Universal Tubing, Child
B.L.S. Systems Limited
6110-U
In Commercial Distribution

  • B0026110U7 ()
  • B0026110U0 ()
  • B0026110U9 ()

  • Child
6110-U

  • Non-rebreathing oxygen face mask
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