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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No Description
IBA Dosimetry GmbH
MQ03-000
In Commercial Distribution

  • EIBAMQ030000 ()


  • Accelerator system quality assurance device
90-Degree Tubing Elbow for CPAP Machines
SUNSET HEALTHCARE SOLUTIONS, INC.
CAP1027
In Commercial Distribution

  • 00848530100346 ()


  • Luer/Luer linear connector, reusable
Eccos Set for 2 Acculan 3Ti machines
Aesculap AG
GB243R
In Commercial Distribution

  • 04046963110352 ()
GB243R

  • Surgical instrument/implant rack
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-142C
CODONICS INC.
500i PCS -142C
In Commercial Distribution

  • 00814905020250 ()


  • Parenteral-nutrition management software
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-141C
CODONICS INC.
500i PCS -141C
In Commercial Distribution

  • 00814905020243 ()


  • Parenteral-nutrition management software
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-140C
CODONICS INC.
500i PCS -140C
In Commercial Distribution

  • 00814905020236 ()


  • Parenteral-nutrition management software
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items
CODONICS INC.
500i PCS
In Commercial Distribution

  • 00814905020229 ()


  • Parenteral-nutrition management software
Administration Tool compatible with Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.2.0
In Commercial Distribution

  • 00814905020144 ()


  • Parenteral-nutrition management software
V2.2.0 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.2.0
In Commercial Distribution

  • 00814905020137 ()


  • Parenteral-nutrition management software
V2.1.0 Administration Tool compatible with Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.0
In Commercial Distribution

  • 00814905020038 ()


  • Parenteral-nutrition management software
V2.1.3 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.3
In Commercial Distribution

  • 00814905020021 ()


  • Parenteral-nutrition management software
V2.1.2 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.2
In Commercial Distribution

  • 00814905020014 ()


  • Parenteral-nutrition management software
V2.1.1 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.1
In Commercial Distribution

  • 00814905020007 ()


  • Parenteral-nutrition management software
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items - 143C
CODONICS INC.
550i PCS - 143C
In Commercial Distribution

  • 00814905020373 ()


  • Parenteral-nutrition management software
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items
CODONICS INC.
550i PCS
In Commercial Distribution

  • 00814905020366 ()


  • Parenteral-nutrition management software
Polishing brush for polishing machines, ø 80 mm
DENTAURUM GmbH & Co.KG
141-710-00
In Commercial Distribution

  • J011141710000 ()


  • Dental abrasive point, reusable
Polishing brush for polishing machines, ø 50 mm
DENTAURUM GmbH & Co.KG
141-700-10
In Commercial Distribution

  • J011141700100 ()


  • Dental abrasive point, reusable
Polishing brush for polishing machines, ø 50 mm
DENTAURUM GmbH & Co.KG
141-700-00
In Commercial Distribution

  • J011141700000 ()


  • Dental abrasive point, reusable
ECCOS FIXATION F/ACCULAN II MACHINES
Aesculap AG
GB509R
Not in Commercial Distribution

  • 04038653356171 ()
GB509R

  • Device sterilization/disinfection container, reusable
Lateral channel adapter for GE anaesthesia, machines, L 200mm
CIM med GmbH
DX-AES-01
In Commercial Distribution

  • 04061162004028 ()


  • Medical monitor/light mount
Cloth polishing brush for polishing machines, ø 100 mm
DENTAURUM GmbH & Co.KG
181-200-00
In Commercial Distribution

  • J011181200000 ()


  • Dental abrasive point, reusable
Palatal cup brush for polishing machines, ø 30 mm
DENTAURUM GmbH & Co.KG
141-713-10
In Commercial Distribution

  • J011141713100 ()


  • Dental abrasive point, reusable
Palatal cup brush for polishing machines, ø 30 mm
DENTAURUM GmbH & Co.KG
141-713-00
In Commercial Distribution

  • J011141713001 ()
  • J011141713000 ()


  • Dental abrasive point, reusable
ADAPTER for leakage test in OLYMPUS endoscope washer-disinfector machines
Richard Wolf GmbH
163905
In Commercial Distribution

  • 04055207008607 ()
163.905

  • Invasive medical device leak tester, mechanical
Chamois leather polishing brush for polishing machines, ø 90 mm
DENTAURUM GmbH & Co.KG
181-201-00
In Commercial Distribution

  • J011181201000 ()


  • Dental abrasive point, reusable
Lateral channel adapter L 320mm, for Dräger Julian / Primus anaesthesia machines
CIM med GmbH
DR-J02
In Commercial Distribution

  • 04061162031031 ()


  • Medical monitor/light mount
Lateral channel adapter L 127mm for Dräger Julian / Primus anaesthesia machines
CIM med GmbH
DR-J01
In Commercial Distribution

  • 04061162003960 ()


  • Medical monitor/light mount
CareMaster Solution Plus for Automatic Machines, Synthetic,1000ml, Made in USA
Beyes Dental Canada Inc
HPLP012
In Commercial Distribution

  • 00628504370377 ()


  • Surgical instrument maintenance lubricant
Small Adapter, VBMAX35 to Collins Pulmonary Function Testing Machines
A-M SYSTEMS, LLC
Adapter, VBMax35 to Collins Mach. - 115523
In Commercial Distribution

  • 00817081023060 ()
  • 00817081023053 ()
115523

  • Breathing mouthpiece, reusable
Sunset Portable Suction Machine with AC/DC Power, 800cc Canister, Detachable Power Cord, Carry Case & Car Adapter
SUNSET HEALTHCARE SOLUTIONS, INC.
SU100DPA
In Commercial Distribution

  • 10848530102576 ()
  • 00848530102579 ()


  • Pneumatic line tester, battery-powered
A reusable device to verify the condition of an interface cable.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684003
In Commercial Distribution

  • 50886333640039 ()
  • 00886333640034 ()
684003

  • Pneumatic line tester, battery-powered
Polishing brush for polishing machines, 3 numbers of brush ranges, ø 60 mm
DENTAURUM GmbH & Co.KG
141-712-00
In Commercial Distribution

  • J011141712001 ()
  • J011141712000 ()


  • Dental abrasive point, reusable
Polishing brush for polishing machines, 2 numbers of brush ranges, ø 60 mm
DENTAURUM GmbH & Co.KG
141-711-00
In Commercial Distribution

  • J011141711001 ()
  • J011141711000 ()


  • Dental abrasive point, reusable
No Description
FLEXICARE MEDICAL LIMITED
032-10-260U
In Commercial Distribution

  • 05055788702122 ()


  • Pressure relief valve, single-use
No Description
FLEXICARE MEDICAL LIMITED
032-12-240U
In Commercial Distribution

  • 05055788702115 ()


  • Pressure relief valve, single-use
MANIFOLD PRESSURE O2 THERAPY
FISHER & PAYKEL HEALTHCARE LIMITED
BC115-05
In Commercial Distribution

  • 09420012420497 ()


  • Pressure relief valve, single-use
F&P Optiflow Flow Diverter
FISHER & PAYKEL HEALTHCARE LIMITED
AA520J
In Commercial Distribution

  • 09420012480149 ()
AA520J

  • Pressure relief valve, reusable
PRESSURE RELIEF MANIFOLD NHF
FISHER & PAYKEL HEALTHCARE LIMITED
OJR215
In Commercial Distribution

  • 09420012445278 ()
  • 09420012445261 ()
OJR215

  • Pressure relief valve, single-use
AirLife DuoTherm® Pressure Relief Valve, 40 cm H2O
AIRLIFE
AH115-05E
In Commercial Distribution

  • 30889483595835 ()
  • 10889483595831 ()
AH115-05E

  • Pressure relief valve, single-use
No Description
Drägerwerk AG & Co. KGaA
MP05507
Not in Commercial Distribution

  • 04048675561316 ()


  • Pressure relief valve, single-use
2008T GEN 2 BIBAG WITHOUT CDX
Fresenius Usa, Inc.
190895
In Commercial Distribution

  • 00840861100927 ()


  • Haemodialysis system, institutional
2008T HEMODIALYSIS SYSTEM W/CDX W/BIBAG
Fresenius Usa, Inc.
190766
In Commercial Distribution

  • 00840861100910 ()


  • Haemodialysis system, institutional
2008T HEMODIALYSIS SYSTEM WITHOUT CDX
Fresenius Usa, Inc.
190858
In Commercial Distribution

  • 00840861100903 ()


  • Haemodialysis system, institutional
2008T HEMODIALYSIS SYS., with CDX
Fresenius Usa, Inc.
190713
In Commercial Distribution

  • 00840861100897 ()


  • Haemodialysis system, institutional
2008K2 HEMO SYSTEM, OPTIONAL 5th MODULE
Fresenius Usa, Inc.
190633
In Commercial Distribution

  • 00840861100873 ()


  • Haemodialysis system, institutional
2008K2 MACHINE, SHORT CAB, OLC/DP, HP
Fresenius Usa, Inc.
190630
In Commercial Distribution

  • 00840861100866 ()


  • Haemodialysis system, institutional
2008K2 HEMODIALYSIS SYS. OLC/ DIASAFE PLS
Fresenius Usa, Inc.
190610
In Commercial Distribution

  • 00840861100859 ()


  • Haemodialysis system, institutional
2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
Fresenius Usa, Inc.
190904
In Commercial Distribution

  • 00840861100965 ()


  • Haemodialysis system, institutional/home-use
2008K@HOME MACHINE, SHORT CAB, OLC/DP,HP
Fresenius Usa, Inc.
190395
In Commercial Distribution

  • 00840861100958 ()


  • Haemodialysis system, institutional/home-use
2008K@HOME HEMODIALYSIS SYSTEM
Fresenius Usa, Inc.
190828
In Commercial Distribution

  • 00840861100941 ()


  • Haemodialysis system, institutional/home-use
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