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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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COE® ADHESIVE Bulk Bottles (Set of 12), 13mL
Gc America Inc.
133912
In Commercial Distribution

  • D6581339121 ()
133912

  • Pharmaceutical fluid-dispensing system
COE® ADHESIVE BOTTLE ONLY, 13mL
Gc America Inc.
133911
In Commercial Distribution

  • D6581339111 ()
133911

  • Pharmaceutical fluid-dispensing system
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
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
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
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
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
Hyperbaric Chamber
Hyperbaric For Life.com, Llc
8003
In Commercial Distribution

  • G625R800340 ()


  • Hyperbaric chamber, stationary
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
MULTI-AD® Transfer Set (MAT4100)
B. BRAUN MEDICAL INC.
513548
In Commercial Distribution

  • 04022495818348 ()
  • 04045928016357 ()
513548

  • Pharmaceutical fluid-dispensing system
MULTI-AD® Fluid Dispensing System
B. BRAUN MEDICAL INC.
513540
In Commercial Distribution

  • 04022495770400 ()
  • 04022495871213 ()
513540

  • Pharmaceutical fluid-dispensing system
MULTI-AD® Fluid Dispensing System
B. BRAUN MEDICAL INC.
513506
In Commercial Distribution

  • 04022495770394 ()
  • 04046963093099 ()
513506

  • Pharmaceutical fluid-dispensing system
MULTI-AD® Fluid Dispensing System
B. BRAUN MEDICAL INC.
513501
In Commercial Distribution

  • 04022495770387 ()
  • 04046964189708 ()
513501

  • Pharmaceutical fluid-dispensing system
Diana Peristaltic Pump
ICU MEDICAL, INC.
DS1000
In Commercial Distribution

  • 00840619099046 ()
DS1000

  • Pharmaceutical fluid-dispensing system
Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CL5300R
In Commercial Distribution

  • 00840619091590 ()
CL5300R

  • Pharmaceutical fluid-dispensing system
Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CL5000
In Commercial Distribution

  • 00840619090876 ()
CL5000

  • Pharmaceutical fluid-dispensing system
Diana Automated Drug Compounding System
ICU MEDICAL, INC.
CL5300
In Commercial Distribution

  • 00840619089894 ()
CL5300

  • Pharmaceutical fluid-dispensing system
The FLAATZ 750E detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 750E
In Commercial Distribution

  • 08800018404102 ()


  • Diagnostic x-ray digital imaging conversion system
The FLAATZ 500 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 500
In Commercial Distribution

  • 08800018404003 ()


  • Diagnostic x-ray digital imaging conversion system
The FLAATZ 760 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 760
In Commercial Distribution

  • 08800018403907 ()


  • Diagnostic x-ray digital imaging conversion system
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