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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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Go Hearing - Go Ultra - Gray - BTE - WAG Online
HEARX GROUP (PTY) LTD
Go Ultra - Gray - BTE - WAG Online
In Commercial Distribution

  • 00810153660057 ()


  • Air-conduction hearing aid, behind-the-ear
Basin wrap 50"x76" 2.25m;on-line lam, 1170pc/glrd
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080562 ()
  • 00683534080566 ()
BW50076-1

  • Medical equipment/instrument drape, single-use
Basin wrap 50"x50" 2.25m;on-line lam,1800pc/G
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080555 ()
  • 00683534080559 ()
BW50050-1

  • Medical equipment/instrument drape, single-use
Go Hearing - Go Ultra - Gray - BTE - WAG Online - CASE
HEARX GROUP (PTY) LTD
Go Ultra - Gray - BTE - WAG Online - CASE
In Commercial Distribution

  • 10810153660054 ()
GHUS00002CA

  • Air-conduction hearing aid, behind-the-ear
CONN TMC50 BIOTREND 1/2 CUVETTE 12PK
MEDTRONIC, INC.
TMC50
In Commercial Distribution

  • 20681490009830 ()
  • 00681490009836 ()

  • Outer Port Diameter 1.27 CM


  • Cardiopulmonary bypass system blood gas sensor
CONN TMC38 BIOTREND 3/8 CUVETTE 12PK
MEDTRONIC, INC.
TMC38
In Commercial Distribution

  • 20681490009823 ()
  • 00681490009829 ()

  • 0.95 CM Port Outer Diameter


  • Cardiopulmonary bypass system blood gas sensor
CONN TMC25 BIOTREND 1/4 CUVETTE 12PK
MEDTRONIC, INC.
TMC25
In Commercial Distribution

  • 20681490009816 ()
  • 00681490009812 ()

  • 0.64 CM Port Outer Diameter


  • Cardiopulmonary bypass system blood gas sensor
Quantum Pressure Sensor Assembly - 2.0m
SPECTRUM MEDICAL LIMITED
QPR6
In Commercial Distribution

  • 05060434423306 ()
51-000139-00

  • Extracorporeal blood gas/pH monitor
Quantum Pressure Sensor Assembly - 1.2m
SPECTRUM MEDICAL LIMITED
QPR5
In Commercial Distribution

  • 05060434423290 ()
51-000138-00

  • Extracorporeal blood gas/pH monitor
Quantum Pressure Sensor Assembly - 0.75m
SPECTRUM MEDICAL LIMITED
QPR4
In Commercial Distribution

  • 05060434423283 ()
51-000137-00

  • Extracorporeal blood gas/pH monitor
Hb/SO2 Twin Sensor ID 3/16" x Wall 1/16" (OD 5/16") - V0.55m, A0.85m
SPECTRUM MEDICAL LIMITED
HBS1-050
In Commercial Distribution

  • 05060434423016 ()
51-000123-00

  • Extracorporeal blood gas/pH monitor
Hb/SO2 Twin Sensor ID 1/4" x Wall 1/16" (OD 3/8") - V0.55m, A0.85m
SPECTRUM MEDICAL LIMITED
HBS2-050
In Commercial Distribution

  • 05060434423009 ()
51-000122-00

  • Extracorporeal blood gas/pH monitor
Hb/SO2 Twin Sensor ID 1/4" x Wall 3/32" (OD 7/16") - V0.55m, A0.85m
SPECTRUM MEDICAL LIMITED
HBS3-050
In Commercial Distribution

  • 05060434422996 ()
51-000121-00

  • Extracorporeal blood gas/pH monitor
Hb/SO2 Twin Sensor ID 3/8" x Wall 3/32" (OD 9/16") - V0.55m, A0.85m
SPECTRUM MEDICAL LIMITED
HBS4-050
In Commercial Distribution

  • 05060434422989 ()
51-000120-00

  • Extracorporeal blood gas/pH monitor
Quantum Workstation 15 Elite
SPECTRUM MEDICAL LIMITED
QWS15E
In Commercial Distribution

  • 05060434422521 ()
51-000100-00

  • Extracorporeal blood gas/pH monitor
Quantum Pressure Sensor Assembly - 2.0m
SPECTRUM MEDICAL LIMITED
QPR3
In Commercial Distribution

  • 05060434422354 ()
51-000097-00

  • Extracorporeal blood gas/pH monitor
Quantum Workstation 12" Elite
SPECTRUM MEDICAL LIMITED
QWS12E
In Commercial Distribution

  • 05060434422309 ()
51-000094-00

  • Extracorporeal blood gas/pH monitor
Quantum Workstation 15"
SPECTRUM MEDICAL LIMITED
QWS15S
In Commercial Distribution

  • 05060434422293 ()
51-000093-00

  • Extracorporeal blood gas/pH monitor
Quantum Workstation 15" Lite
SPECTRUM MEDICAL LIMITED
QWS15L
In Commercial Distribution

  • 05060434422279 ()
51-000091-00

  • Extracorporeal blood gas/pH monitor
Quantum Pressure Sensor Assembly - 0.75m
SPECTRUM MEDICAL LIMITED
QPR2
In Commercial Distribution

  • 05060434422231 ()
51-000088-00

  • Extracorporeal blood gas/pH monitor
Quantum Workstation 12"
SPECTRUM MEDICAL LIMITED
QWS12
In Commercial Distribution

  • 05060434420718 ()
51-000031-00

  • Extracorporeal blood gas/pH monitor
Quantum Diagnostic Module
SPECTRUM MEDICAL LIMITED
QDM1
In Commercial Distribution

  • 05060434420701 ()
51-000023-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS1-130
In Commercial Distribution

  • 05060434420671 ()
51-000044-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS3-130
In Commercial Distribution

  • 05060434420657 ()
51-000042-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 2m
SPECTRUM MEDICAL LIMITED
HBS1-200
In Commercial Distribution

  • 05060434420633 ()
51-000040-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 2m
SPECTRUM MEDICAL LIMITED
HBS3-200
In Commercial Distribution

  • 05060434420619 ()
51-000038-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 2m
SPECTRUM MEDICAL LIMITED
HBS4-200
In Commercial Distribution

  • 05060434420602 ()
51-000037-00

  • Extracorporeal blood gas/pH monitor
SO2 SO2 Twin
SPECTRUM MEDICAL LIMITED
SO2 Sensor
In Commercial Distribution

  • 05060434420237 ()
3003-001-010

  • Extracorporeal blood gas/pH monitor
Exhaust Module for use with Gas Modules as part of Gas Management System
SPECTRUM MEDICAL LIMITED
Exhaust Module
In Commercial Distribution

  • 05060434420206 ()
3003-031-005

  • Extracorporeal blood gas/pH monitor
High Flow - (1.0 - 7.0 L/min)
SPECTRUM MEDICAL LIMITED
Gas Module
Not in Commercial Distribution

  • 05060434420190 ()
3003-030-010

  • Extracorporeal blood gas/pH monitor
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