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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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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

GC CARTRIDGE DISPENSER II - D6581521611

GC CARTRIDGE DISPENSER II Plunger, 48mL
Gc America Inc.
152161
In Commercial Distribution

  • D6581521611 ()
152161

  • Pharmaceutical fluid-dispensing system

GC CARTRIDGE DISPENSER II - D6581521021

GC CARTRIDGE DISPENSER II 75mL
Gc America Inc.
152102
In Commercial Distribution

  • D6581521021 ()
152102

  • Pharmaceutical fluid-dispensing system

GC CARTRIDGE DISPENSER II - D6581521011

GC CARTRIDGE DISPENSER II 48mL
Gc America Inc.
152101
In Commercial Distribution

  • D6581521011 ()
152101

  • Pharmaceutical fluid-dispensing system

NA - D6581520811

PLUNGER FOR UNIVERSAL DISPENSER
Gc America Inc.
152081
In Commercial Distribution

  • D6581520811 ()
152081

  • Pharmaceutical fluid-dispensing system

Mixing Tips - D6581501001

100 INTRAORAL TIPS UNIVERSAL/NDS
Gc America Inc.
150100
In Commercial Distribution

  • D6581501001 ()
  • D6581501000 ()
150100

  • Pharmaceutical fluid-dispensing system

COE® Adhesive - D6581339121

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

  • D6581339121 ()
133912

  • Pharmaceutical fluid-dispensing system

COE® Adhesive - D6581339111

COE® ADHESIVE BOTTLE ONLY, 13mL
Gc America Inc.
133911
In Commercial Distribution

  • D6581339111 ()
133911

  • Pharmaceutical fluid-dispensing system

FDR ES II C25 - 04547410549300

The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1285 SE FF E
In Commercial Distribution

  • 04547410549300 ()


  • Diagnostic x-ray digital imaging conversion system

FDR ES II C43 - 04547410549294

The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1284 SE FF E
In Commercial Distribution

  • 04547410549294 ()


  • Diagnostic x-ray digital imaging conversion system

FDR ES II C35 - 04547410549287

The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1283 SE FF E
In Commercial Distribution

  • 04547410549287 ()


  • Diagnostic x-ray digital imaging conversion system
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