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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Nylon Restraint Strap with Gel Mid Panel
David Scott Company
BD500-G
In Commercial Distribution

  • 15060797554171 ()
BD500-G

  • Medical table restraint anchor
Drugs of Abuse Test Cut 14 panel
MCKESSON MEDICAL-SURGICAL INC.
164-DXA14
In Commercial Distribution

  • 20612479215423 ()
  • 10612479224572 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Cup 12 panel
MCKESSON MEDICAL-SURGICAL INC.
164-DXA12
In Commercial Distribution

  • 20612479215416 ()
  • 10612479224565 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Cup 10 panel
MCKESSON MEDICAL-SURGICAL INC.
164-DXA10
In Commercial Distribution

  • 20612479215409 ()
  • 10612479224558 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Cup 8 panel
MCKESSON MEDICAL-SURGICAL INC.
164-DXA8
In Commercial Distribution

  • 20612479215393 ()
  • 10612479224541 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Sterile Labels - Custom, Liquid Medicines, 10 labels per panel, 1 panel per pouch, 100 pouches per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 20849771052825 ()
  • 10849771052828 ()
  • 00849771052821 ()
  • 00849771035466 ()
SL113

  • Procedural medication labelling set
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
9897-010-01041
In Commercial Distribution

  • 00884838065239 ()
712090

  • Diagnostic x-ray digital imaging conversion system
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
9897-010-01041
In Commercial Distribution

  • 00884838074538 ()
712090

  • Diagnostic x-ray digital imaging conversion system
Automatic system for filling syringes
AEA SRL
APOTECAsyringe
In Commercial Distribution

  • 05060304050250 ()


  • Pharmaceutical fluid-dispensing system
Automatic system for compouding of non-hazardous drugs for pedriatic patients
AEA SRL
APOTECAped
In Commercial Distribution

  • 05060304050243 ()


  • Pharmaceutical fluid-dispensing system
No Description
AEA SRL
APOTECAunit
In Commercial Distribution

  • 05060304050199 ()


  • Pharmaceutical fluid-dispensing system
No Description
AEA SRL
APOTECAchemo
In Commercial Distribution

  • 05060304050182 ()


  • Pharmaceutical fluid-dispensing system
Mixing Pen
Onpharma Company
540-01
In Commercial Distribution

  • 00860001977318 ()


  • Pharmaceutical fluid-dispensing system
The HMS-1000 hyperbaric chamber series is a Class B, monoplace hyperbaric chamber designed to treat one (1) patient to a maximum operating pressure of three (3) Atmospheres Absolute (ATA) (~ 29.4 psi). The chamber uses 100% oxygen as both the pressurization and hyperbaric treatment gas. The overall external length of the horizontal cylinder configuration is 8.75 feet. Its internal diameter is 33.5 inches. It is constructed of acrylic, aluminum, and fine-grade steel. Single operator pressure control is achieved via a simple industrial Programmable Logic Device (PLD) controller. A low-voltage patient intercom provides communications between the patient in the chamber and the external chamber operators. HMS-1000 is designed, fabricated, and tested in compliance with the following FDA consensus standards: the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Hyperbaric Modular Systems Inc.
HMS-1000
In Commercial Distribution

  • 00860006478964 ()


  • Hyperbaric chamber, stationary
The HMS-2000 is a Class A, single compartment pressure vessel for human occupancy (PVHO) that is oriented in a vertical cylindrical geometry. The HMS-2000 hyperbaric chamber family of products is designed with non-dedicated seating, providing flexibility in managing seating arrangements. The diameter of the HMS-2000 varies in size; thereby enabling the ability to increase the patient capacity from three (3) to four (4) seated patients. An extension nozzle is attached to the chamber hull which provides the unique capability to treat one (1) patient in the supine versus seated position. The maximum allowable working pressure is three (3) Atmospheres Absolute (ATA) (~29.4psi). The control and operation of the HMS-2000 is performed from a hull mounted control console. The HMS-2000 multiplace hyperbaric chamber is designed, fabricated, and tested in compliance with the following FDA consensus standards: the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Hyperbaric Modular Systems Inc.
HMS-2000
In Commercial Distribution

  • 00860006478940 ()


  • Hyperbaric chamber, stationary
The HMS-4000 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a horizontal cylindrical geometry. Configurations vary from one (1) to three (3) compartments. These chambers are capable of administering hyperbaric oxygen therapy treatments to four (4) up to twenty-four (24) patients simultaneously. These chamber models comprise the HMS 4000 Horizontal Cylindrical Multiplace Hyperbaric Chamber System Product Family. Each system consists of a multiplace hyperbaric chamber with several major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Design pressures range from 3ATA (~29.4psi) up to 6ATA (~73.5psi). The HMS-4000 multiplace hyperbaric chamber is designed, fabricated, and tested in compliance with the following FDA consensus standards: American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Hyperbaric Modular Systems Inc.
HMS-4000
In Commercial Distribution

  • 00860006478926 ()


  • Hyperbaric chamber, stationary
The HMS-5000-12-COMPACT-QUADRO is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two (2) compartments which are pressurized with air used for administering hyperbaric oxygen therapy treatments up to twelve (12) patients simultaneously at a pressure up to 3 atmospheres absolute (3ATA). It is designed, fabricated, and tested in compliance with the following FDA consensus standards: American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Hyperbaric Modular Systems Inc.
HMS-5000-12-COMPACT-QUADRO
In Commercial Distribution

  • 00860006478919 ()


  • Hyperbaric chamber, stationary
The HMS-5000-12 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two (2) compartments and is capable of administering hyperbaric oxygen therapy treatments up to twelve (12) patients simultaneously. It is one of the models contained within the HMS 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family. It is comprised of a multiplace hyperbaric chamber with a number of major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Pressures up to 6ATA (~73.5psi). The HMS-5000 multiplace hyperbaric chamber is designed, fabricated, and tested in compliance with the following FDA consensus standards: American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Hyperbaric Modular Systems Inc.
HMS-5000-12
In Commercial Distribution

  • 00860006478902 ()


  • Hyperbaric chamber, stationary
Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor
Reina Imaging
WDDR[X]
In Commercial Distribution

  • 00860001700176 ()


  • Footstool
  • Flat panel x-ray detector/film cassette weight-bearing protector
HBO CHMBR.ASSY.41IN,STD.ENGLISH, PLATINUM
SECHRIST INDUSTRIES, INC.
4100HP-03-1
In Commercial Distribution

  • 00852682007996 ()

  • Depth: 116 Inch
  • Weight: 3500 Pound
  • Height: 85 Inch
  • Width: 55 Inch


  • Hyperbaric chamber, stationary
HBO,CHMBR.ASSY.36IN,ENGLISH,BEIGE, STORAGE
SECHRIST INDUSTRIES, INC.
3600H-02-1
In Commercial Distribution

  • 00852682007958 ()

  • Width: 53 Inch
  • Height: 81 Inch
  • Weight: 2220 Pound
  • Depth: 112 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR.ASSY.36IN,RVRS.ENGLISH,BEIGE, STORAGE
SECHRIST INDUSTRIES, INC.
3600HR-02-1
In Commercial Distribution

  • 00852682007941 ()

  • Width: 53 Inch
  • Height: 81 Inch
  • Weight: 2220 Pound
  • Depth: 112 Inch


  • Hyperbaric chamber, stationary
HBO CHMBER,36IN,ELECT CNTRL,ENGLISH,BLUE
SECHRIST INDUSTRIES, INC.
3600E-00
In Commercial Distribution

  • 00852682007934 ()

  • Width: 53 Inch
  • Height: 81 Inch
  • Weight: 2220 Pound
  • Depth: 112 Inch


  • Hyperbaric chamber, stationary
HBO CHMBER,32IN PNMTC,REVRS,ENGLISH,BLUE
SECHRIST INDUSTRIES, INC.
3200R-00
In Commercial Distribution

  • 00852682007927 ()

  • Depth: 103 Inch
  • Width: 53 Inch
  • Height: 77 Inch
  • Weight: 2030 Pound


  • Hyperbaric chamber, stationary
HBO CHMBER,32IN,PNMTC,ENGLISH,BLUE
SECHRIST INDUSTRIES, INC.
3200-00
In Commercial Distribution

  • 00852682007903 ()

  • Weight: 2030 Pound
  • Height: 77 Inch
  • Width: 53 Inch
  • Depth: 103 Inch


  • Hyperbaric chamber, stationary
3300HRP-00-0 HBO CHMBR.ASSY.33IN,RVRS.ENGLISH, BLUE, CLASSIC
SECHRIST INDUSTRIES, INC.
3300HRP-00-0
In Commercial Distribution

  • 00852682007897 ()

  • Weight: 2030 Pound
  • Height: 77 Inch
  • Width: 53 Inch
  • Depth: 103 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR.ASSY.41IN.RVRS.ENGLISH PLATINUM, STORAGE
SECHRIST INDUSTRIES, INC.
4100HRP-03-1
In Commercial Distribution

  • 00852682007842 ()

  • Depth: 116 Inch
  • Weight: 3500 Pound
  • Height: 85 Inch
  • Width: 55 Inch


  • Hyperbaric chamber, stationary
4100HRP CHMBR.ASSY.41IN.RVRS.ENGLISH,WHITE,STORAGE
SECHRIST INDUSTRIES, INC.
4100HRP-01-1
In Commercial Distribution

  • 00852682007774 ()

  • Width: 55 Inch
  • Height: 85 Inch
  • Weight: 3500 Pound
  • Depth: 116 Inch


  • Hyperbaric chamber, stationary
4100HP CHMBR.ASSY.41IN,ENGLISH,WHITE, STORAGE
SECHRIST INDUSTRIES, INC.
4100HP-01-1
In Commercial Distribution

  • 00852682007767 ()

  • Depth: 116 Inch
  • Weight: 3500 Pound
  • Height: 85 Inch
  • Width: 55 Inch


  • Hyperbaric chamber, stationary
4100HRP CHMBR.ASSY.41IN.RVRS.ENGLISH,BLUE,STORAGE
SECHRIST INDUSTRIES, INC.
4100HRP-00-1
In Commercial Distribution

  • 00852682007750 ()

  • Width: 55 Inch
  • Height: 85 Inch
  • Weight: 3500 Pound
  • Depth: 116 Inch


  • Hyperbaric chamber, stationary
4100HP CHMBR.ASSY.41IN,ENGLISH,BLUE,STORAGE
SECHRIST INDUSTRIES, INC.
4100HP-00-1
In Commercial Distribution

  • 00852682007743 ()

  • Depth: 116 Inch
  • Weight: 3500 Pound
  • Height: 85 Inch
  • Width: 55 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR.ASSY.REVERSE,ENGLISH,WHITE, STORAGE
SECHRIST INDUSTRIES, INC.
3600HRP-01-1
In Commercial Distribution

  • 00852682007736 ()

  • Weight: 2220 Pound
  • Height: 81 Inch
  • Width: 53 Inch
  • Depth: 112 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR.ASSY.36IN,ENGLISH,WHITE, STORAGE
SECHRIST INDUSTRIES, INC.
3600HP-01-1
In Commercial Distribution

  • 00852682007729 ()

  • Depth: 112 Inch
  • Width: 53 Inch
  • Height: 81 Inch
  • Weight: 2220 Pound


  • Hyperbaric chamber, stationary
HBO CHAMBER ASSY.36IN, REVERSE,ENGLISH,BLUE,STORAGE
SECHRIST INDUSTRIES, INC.
3600HRP-00-1
In Commercial Distribution

  • 00852682007712 ()

  • Weight: 2220 Pound
  • Height: 81 Inch
  • Width: 53 Inch
  • Depth: 112 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR.ASSY.36IN,ENGLISH,BLUE,STORAGE
SECHRIST INDUSTRIES, INC.
3600HP-00-1
In Commercial Distribution

  • 00852682007705 ()

  • Depth: 112 Inch
  • Width: 53 Inch
  • Height: 81 Inch
  • Weight: 2220 Pound


  • Hyperbaric chamber, stationary
3300HRP CHMBR.ASSY.RVRS.33IN.ENGLISH,WHITE,STORAGE
SECHRIST INDUSTRIES, INC.
3300HRP-01-1
In Commercial Distribution

  • 00852682007699 ()

  • Depth: 103 Inch
  • Width: 53 Inch
  • Height: 77 Inch
  • Weight: 2030 Pound


  • Hyperbaric chamber, stationary
3300HP CHMBR.ASSY.33IN.ENGLISH WHITE,STORAGE
SECHRIST INDUSTRIES, INC.
3300HP-01-1
In Commercial Distribution

  • 00852682007682 ()

  • Weight: 2030 Pound
  • Height: 77 Inch
  • Width: 53 Inch
  • Depth: 103 Inch


  • Hyperbaric chamber, stationary
3300HRP CHMBR.ASSY.33IN,RVRS.ENGLISH,BLUE,STORAGE
SECHRIST INDUSTRIES, INC.
3300HRP-00-1
In Commercial Distribution

  • 00852682007675 ()

  • Depth: 103 Inch
  • Width: 53 Inch
  • Height: 77 Inch
  • Weight: 2030 Pound


  • Hyperbaric chamber, stationary
3300HP CHMBR.ASSY. 33IN.ENGLISH BLUE, STORAGE
SECHRIST INDUSTRIES, INC.
3300HP-00-1
In Commercial Distribution

  • 00852682007668 ()

  • Weight: 2030 Pound
  • Height: 77 Inch
  • Width: 53 Inch
  • Depth: 103 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR.ASSY.33IN,RVRS.ENGLISH,PLATINUM, STORAGE
SECHRIST INDUSTRIES, INC.
3300HR-03-1
In Commercial Distribution

  • 00852682007651 ()

  • Depth: 103 Inch
  • Width: 53 Inch
  • Height: 77 Inch
  • Weight: 2030 Pound


  • Hyperbaric chamber, stationary
HBO CHMBR,ASSY,33IN,ENGLISH,BLUE
SECHRIST INDUSTRIES, INC.
3300H-00
In Commercial Distribution

  • 00852682007637 ()

  • Weight: 2030 Pound
  • Height: 77 Inch
  • Width: 53 Inch
  • Depth: 103 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR.ASSY.41IN,RVRS.ENGLISH,CRYSTAL GREEN,STORAG
SECHRIST INDUSTRIES, INC.
4100HR-04-1
In Commercial Distribution

  • 00852682007620 ()

  • Width: 55 Inch
  • Height: 85 Inch
  • Weight: 3500 Pound
  • Depth: 116 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR.ASSY.41IN,ENGLICH,CRYSTAL GREEN, STORAGE
SECHRIST INDUSTRIES, INC.
4100H-04-1
In Commercial Distribution

  • 00852682007613 ()

  • Width: 55 Inch
  • Height: 85 Inch
  • Weight: 3500 Pound
  • Depth: 116 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR ASSY.41IN.RVRS.ENGLISH,BEIGE,STORAGE
SECHRIST INDUSTRIES, INC.
4100HR-02-1
In Commercial Distribution

  • 00852682007576 ()

  • Depth: 116 Inch
  • Weight: 3500 Pound
  • Height: 85 Inch
  • Width: 55 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR ASSY.41IN,ENGLISH,SAHARA BEIGE,STORAGE
SECHRIST INDUSTRIES, INC.
4100H-02-1
In Commercial Distribution

  • 00852682007569 ()

  • Width: 55 Inch
  • Height: 85 Inch
  • Weight: 3500 Pound
  • Depth: 116 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR,ASSY,41IN,ENGLISH,WHITE,CLASSIC
SECHRIST INDUSTRIES, INC.
4100H-01-0
In Commercial Distribution

  • 00852682007552 ()

  • Depth: 116 Inch
  • Weight: 3500 Pound
  • Height: 85 Inch
  • Width: 55 Inch


  • Hyperbaric chamber, stationary
HBO CHMBER,33IN,ELECT CNTRL,REVRS,ENGLISH,BLUE
SECHRIST INDUSTRIES, INC.
3300ER-00
In Commercial Distribution

  • 00852682007514 ()

  • Weight: 2030 Pound
  • Height: 77 Inch
  • Width: 53 Inch
  • Depth: 103 Inch


  • Hyperbaric chamber, stationary
HBO CHMBER,33IN,ELECT CNTRL,ENGLISH,BLUE
SECHRIST INDUSTRIES, INC.
3300E-00
In Commercial Distribution

  • 00852682007507 ()

  • Depth: 103 Inch
  • Width: 53 Inch
  • Height: 77 Inch
  • Weight: 2030 Pound


  • Hyperbaric chamber, stationary
HBO CHMBER,28IN PNMTC, ENGLISH REVERSED
SECHRIST INDUSTRIES, INC.
2800R
In Commercial Distribution

  • 00852682007453 ()

  • Weight: 1200 Pound
  • Height: 51 Inch
  • Width: 39 Inch
  • Depth: 99 Inch


  • Hyperbaric chamber, stationary
HBO CHMBR.ASSY.36IN.RVRS.ENGLISH,BLUE,STORAGE, HIGH
SECHRIST INDUSTRIES, INC.
3600HR-H-00-1
In Commercial Distribution

  • 00852682007392 ()

  • Width: 53 Inch
  • Height: 81 Inch
  • Weight: 2220 Pound
  • Depth: 112 Inch


  • Hyperbaric chamber, stationary
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