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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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Sechrist Industries, Inc. - 00899660002079

HBO CHMBR,ASSY,36IN,ENGLISH,BLUE,CLASSIC
SECHRIST INDUSTRIES, INC.
3600H-00-0
In Commercial Distribution

  • 00899660002079 ()

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


  • Hyperbaric chamber, stationary

Sechrist Industries, Inc. - 00899660002062

HBO CHMBR,ASSY,33IN,RVRS,ENGLISH,WHITE,STORAGE
SECHRIST INDUSTRIES, INC.
3300HR-01-1
In Commercial Distribution

  • 00899660002062 ()

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


  • Hyperbaric chamber, stationary

Sechrist Industries, Inc. - 00899660002055

HBO CHMBR,ASSY,33IN,RVRS,ENGLISH,WHITE,CLASSIC
SECHRIST INDUSTRIES, INC.
3300HR-01-0
In Commercial Distribution

  • 00899660002055 ()

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


  • Hyperbaric chamber, stationary

Sechrist Industries, Inc. - 00899660002048

HBO CHMBR,ASSY,33IN,RVRS,ENGLISH,BLUE,STORAGE
SECHRIST INDUSTRIES, INC.
3300HR-00-1
In Commercial Distribution

  • 00899660002048 ()

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


  • Hyperbaric chamber, stationary

Sechrist Industries, Inc. - 00899660002031

HBO CHMBR,ASSY,33IN,ENGLISH,WHITE,STORAGE
SECHRIST INDUSTRIES, INC.
3300H-01-1
In Commercial Distribution

  • 00899660002031 ()

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


  • Hyperbaric chamber, stationary

Sechrist Industries, Inc. - 00899660002024

HBO CHMBR,ASSY,33IN,ENGLISH,BLUE,STORAGE
SECHRIST INDUSTRIES, INC.
3300H-00-1
In Commercial Distribution

  • 00899660002024 ()

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


  • Hyperbaric chamber, stationary

Sechrist Industries, Inc. - 00899660002017

HBO CHMBR,ASSY,33IN,ENGLISH,BLUE,CLASSIC
SECHRIST INDUSTRIES, INC.
3300H-00-0
In Commercial Distribution

  • 00899660002017 ()

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


  • Hyperbaric chamber, stationary

Sechrist Industries, Inc. - 00899660002000

HBOCHMBR.ASSY.33IN.ENGLISH,WHITE,STORAGE,HIGH
SECHRIST INDUSTRIES, INC.
3300H-H-01-1
In Commercial Distribution

  • 00899660002000 ()

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


  • Hyperbaric chamber, stationary

Hyperbaric for Life - G625R800340

Hyperbaric Chamber
Hyperbaric For Life.com, Llc
8003
In Commercial Distribution

  • G625R800340 ()


  • Hyperbaric chamber, stationary

US Hyperbaric Network - G623430

The Portable Hyperbaric Chamber Revitalair® 430+ is a hyperbaric semi-rigid chamber for low pressures (operating at pressures of no greater than 1.5 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012).
US Hyperbaric Network LLC
430+
In Commercial Distribution

  • G623430 ()


  • Hyperbaric chamber, stationary

GRI-FILL - 08426314948258

GRI-FILL is a pharmacy compounding device (PCD) and as such is an electromechanical device controlled by software intended to deliver a specified concentration or proportion of ingredients different from the initial solutions.
LABORATORIOS GRIFOLS SA
-
In Commercial Distribution

  • 08426314948258 ()


  • Pharmaceutical fluid-dispensing system

Multiplace Hyperbaric Oxygen Treatment Chamber - B718TL20287CM090

A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
TL20
In Commercial Distribution

  • B718TL20287CM090 ()
TL20287CM09

  • Hyperbaric chamber, stationary

Multiplace Hyperbaric Oxygen Treatment Chamber - B718TL20287CM060

A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
TL20
In Commercial Distribution

  • B718TL20287CM060 ()
TL20287CM06

  • Hyperbaric chamber, stationary

Multiplace Hyperbaric Oxygen Treatment Chamber - B718DL82130

A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
DL8
In Commercial Distribution

  • B718DL82130 ()
DL8213

  • Hyperbaric chamber, stationary

Multiplace Hyperbaric Oxygen Treatment Chamber - B718DL82030

A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
DL8
In Commercial Distribution

  • B718DL82030 ()
DL8203

  • Hyperbaric chamber, stationary

NA - 08806090171147

The GR40CW and GR40CWD Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CWD
In Commercial Distribution

  • 08806090171147 ()


  • Diagnostic x-ray digital imaging conversion system

NA - 08806088773797

The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CW
In Commercial Distribution

  • 08806088773797 ()


  • Diagnostic x-ray digital imaging conversion system

NA - 08806088538440

The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CW
In Commercial Distribution

  • 08806088538440 ()


  • Diagnostic x-ray digital imaging conversion system

NA - 08801643676568

The GR40CW and GR40CWC Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CWC
In Commercial Distribution

  • 08801643676568 ()


  • Diagnostic x-ray digital imaging conversion system

Diana Peristaltic Pump Module - 00840619099046

Diana Peristaltic Pump
ICU MEDICAL, INC.
DS1000
In Commercial Distribution

  • 00840619099046 ()
DS1000

  • Pharmaceutical fluid-dispensing system

DianaTM Automated Drug Compounding System - 00840619091590

Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CL5300R
In Commercial Distribution

  • 00840619091590 ()
CL5300R

  • Pharmaceutical fluid-dispensing system

DianaTM Automated Drug Compounding System - 00840619090876

Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CL5000
In Commercial Distribution

  • 00840619090876 ()
CL5000

  • Pharmaceutical fluid-dispensing system

DianaTM Automated Drug Compounding System - 00840619089894

Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CL5300
In Commercial Distribution

  • 00840619089894 ()
CL5300

  • Pharmaceutical fluid-dispensing system

DianaTM Automated Drug Compounding System - 00840619065058

Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CH5000R
In Commercial Distribution

  • 00840619065058 ()
CH5000R

  • Pharmaceutical fluid-dispensing system

DianaTM Automated Drug Compounding System - 00840619054908

Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CH5000
In Commercial Distribution

  • 00840619054908 ()
CH5000

  • Pharmaceutical fluid-dispensing system

MULTI-AD® - 04022495818348

MULTI-AD® Transfer Set (MAT4100)
B. BRAUN MEDICAL INC.
513548
In Commercial Distribution

  • 04022495818348 ()
  • 04045928016357 ()
513548

  • Pharmaceutical fluid-dispensing system

MULTI-AD® - 04022495770400

MULTI-AD® Fluid Dispensing System
B. BRAUN MEDICAL INC.
513540
In Commercial Distribution

  • 04022495770400 ()
  • 04022495871213 ()
513540

  • Pharmaceutical fluid-dispensing system

MULTI-AD® - 04022495770394

MULTI-AD® Fluid Dispensing System
B. BRAUN MEDICAL INC.
513506
In Commercial Distribution

  • 04022495770394 ()
  • 04046963093099 ()
513506

  • Pharmaceutical fluid-dispensing system

MULTI-AD® - 04022495770387

MULTI-AD® Fluid Dispensing System
B. BRAUN MEDICAL INC.
513501
In Commercial Distribution

  • 04022495770387 ()
  • 04046964189708 ()
513501

  • Pharmaceutical fluid-dispensing system

PCCI Hyperbaric Systems - 00850011262016

The Althea 4200 chamber system is a monoplace hyperbaric chamber outfitted with a large round door. The chamber is pressurized with air, and oxygen is delivered via hood or mask. Pressure and depressurization controls can either be operated manually or automatically. The chamber includes an intercom system that allows two-way communication between the operator and the patient. The chamber is designed to fit through a commonly available 48” doorway.
PCCI HYPERBARIC SYSTEMS
Althea 4200
In Commercial Distribution

  • 00850011262016 ()


  • Hyperbaric chamber, stationary

PCCI Hyperbaric Systems - 00850011262009

Hyperbaric Chamber System: Model 7806D Medical Air Lock, 78" diameter. Dual lock, rated for 6 persons in Main Lock and 2 persons in Entry Lock.
PCCI HYPERBARIC SYSTEMS
7806D Medical Air Lock
In Commercial Distribution

  • 00850011262009 ()


  • Hyperbaric chamber, stationary

TEKNA Manufacturing Pvt. Ltd. - 08906124943068

Modular Multiplace Hyperbaric Chamber consisting of ASME 'U' Stamped pressure vessel that can accommodate 2 patients in the main lock and a control console for the same. The entire system is ASME PVHO-1 Compliant.
TEKNA MANUFACTURING PRIVATE LIMITED
Modular Rectangular 6000 0 2 0 S/L
In Commercial Distribution

  • 08906124943068 ()
Modular Rectangular 6000 0 2 0 S/L

  • Hyperbaric chamber, stationary

TEKNA Manufacturing Pvt. Ltd. - 08906124943051

Modular Multiplace Hyperbaric Chamber consisting of ASME 'U' Stamped pressure vessel that can accommodate 2 patients in the main lock and a control console for the same. The entire system is ASME PVHO-1 Compliant.
TEKNA MANUFACTURING PRIVATE LIMITED
Modular Rectangular 6000 0 0 2 S/L
In Commercial Distribution

  • 08906124943051 ()
Modular Rectangular 6000 0 0 2 S/L

  • Hyperbaric chamber, stationary

TEKNA Manufacturing Pvt. Ltd. - 08906124941477

Hybrid 3200 Series Monoplace Hyperbaric Chamber consisting of ASME 'U' stamped pressure vessel that can accommodate 1 patient in the chamber and a control console for the same. The entire system is ASME PVHO-1 compliant.
TEKNA MANUFACTURING PRIVATE LIMITED
Hybrid 3200 series Monoplace Hyperbaric Chamber
In Commercial Distribution

  • 08906124941477 ()
Hybrid 3200/40 Monoplace Hyperbaric Chamber

  • Hyperbaric chamber, stationary

TEKNA Manufacturing Pvt. Ltd. - 08906124940012

Modular Multiplace Hyperbaric Chamber consisting of ASME 'U' Stamped pressure vessel that can accommodate 8 patients in the main lock and 2 patients in the entry lock and a control console for the same. The entire system is ASME PVHO-1 Compliant.
TEKNA MANUFACTURING PRIVATE LIMITED
Modular Rectangular 6000 + 0 0 8 2 D/L
In Commercial Distribution

  • 08906124940012 ()
Modular Rectangular 6000 + 0 0 8 2 D/L

  • Hyperbaric chamber, stationary

TEKNA Manufacturing Pvt. Ltd. - 08906124940005

Modular Multiplace hyperbaric chamber consisting of ASME 'U' stamped pressure vessel that can accommodate 8 patients in the main lock and 2 patients in the entry lock and a control console for the same. The entire system is ASME PVHO-1 compliant.
TEKNA MANUFACTURING PRIVATE LIMITED
Modular Rectangular 6000 + 0 0 8 2 D/L
In Commercial Distribution

  • 08906124940005 ()


  • Hyperbaric chamber, stationary

Mixing Tips - D6581531481

Mixing Tips 48 x MIXING TIPS INJECTION NDS PINK
Gc America Inc.
153148
In Commercial Distribution

  • D6581531481 ()
  • D6581531480 ()
153148

  • Pharmaceutical fluid-dispensing system

Mixing Tips - D6581530481

Mixing Tips 48 x MIXING TIPS HEAVY NDS PURPLE
Gc America Inc.
153048
In Commercial Distribution

  • D6581530481 ()
  • D6581530480 ()
153048

  • Pharmaceutical fluid-dispensing system

Mixing Tips - D6581530121

Mixing Tips 12 x MIXING TIPS AQUA TYPE 2L NDS
Gc America Inc.
153012
In Commercial Distribution

  • D6581530121 ()
  • D6581530120 ()
153012

  • Pharmaceutical fluid-dispensing system

GC CARTRIDGE DISPENSER II - D6581521711

GC CARTRIDGE DISPENSER II Plunger Conversion Kit, 75mL
Gc America Inc.
152171
In Commercial Distribution

  • D6581521711 ()
152171

  • Pharmaceutical fluid-dispensing system
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