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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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ProtekDuo - 00814112020418

TandemHeart blood pump kit with 31 Fr veno-venous cannula
CARDIACASSIST, INC.
5720-3118
Not in Commercial Distribution

  • 00814112020418 ()


  • Cardiopulmonary bypass system mounting unit
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system centrifugal pump

ProtekDuo - 00814112020401

TandemHeart blood pump kit with 29 Fr veno-venous cannula
CARDIACASSIST, INC.
5720-2916
Not in Commercial Distribution

  • 00814112020401 ()


  • Cardiopulmonary bypass system mounting unit
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system centrifugal pump

PROTEK Duo - 00814112020173

TandemHeart blood pump kit with veno-venous cannula
CARDIACASSIST, INC.
5190-0020
Not in Commercial Distribution

  • 00814112020173 ()


  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
  • Mobile extracorporeal gas exchange system catheter kit

Medline - 10888277699526

SZ 4, DISP, SOFT, MASK, LARYNGEAL, PVC
MEDLINE INDUSTRIES, INC.
DYND300040S
In Commercial Distribution

  • 20888277699523 ()
  • 10888277699526 ()
DYND300040S

  • Laryngeal mask airway, single-use
  • Oropharyngeal airway, single-use

Medline - 20888277367996

50MM,BLUE,SOFT GUEDEL AIRWAY
MEDLINE INDUSTRIES, INC.
DYNJGUED50
In Commercial Distribution

  • 10888277367999 ()
  • 20888277367996 ()
DYNJGUED50

  • Oropharyngeal airway, single-use
  • Laryngeal mask airway, single-use

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937678

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8224
In Commercial Distribution

  • 04710961937678 ()
  • 14710961937675 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937661

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8222
In Commercial Distribution

  • 04710961937661 ()
  • 14710961937668 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937654

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8220
In Commercial Distribution

  • 04710961937654 ()
  • 14710961937651 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937647

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8218
In Commercial Distribution

  • 04710961937647 ()
  • 14710961937644 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937630

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8216
In Commercial Distribution

  • 04710961937630 ()
  • 14710961937637 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937623

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8214
In Commercial Distribution

  • 04710961937623 ()
  • 14710961937620 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937616

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8212
In Commercial Distribution

  • 04710961937616 ()
  • 14710961937613 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934257

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8224
In Commercial Distribution

  • 04710961934257 ()
  • 14710961934254 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934240

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8222
In Commercial Distribution

  • 04710961934240 ()
  • 14710961934247 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934233

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8220
In Commercial Distribution

  • 04710961934233 ()
  • 14710961934230 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934226

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8218
In Commercial Distribution

  • 04710961934226 ()
  • 14710961934223 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934219

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8216
In Commercial Distribution

  • 04710961934219 ()
  • 14710961934216 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934202

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8214
In Commercial Distribution

  • 04710961934202 ()
  • 14710961934209 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934196

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8212
In Commercial Distribution

  • 04710961934196 ()
  • 14710961934193 ()


  • Suprapubic drainage catheter

Source Exchange Tube for Container T41, Ir-192 - 04049223106058

No Description
Eckert & Ziegler BEBIG GmbH
LAZ20-04
Not in Commercial Distribution

  • 04049223106058 ()
LAZ20-04

  • Brachytherapy system remote afterloading source safe

B.BRAUN - 04046963845797

H.E.L.P. HEMOSELECT L 0,5
B.Braun Avitum AG
7061007C
Not in Commercial Distribution

  • 04046963845797 ()
  • 04046963847401 ()

  • Area/Surface Area: 0.5 Square meter
7061007C

  • Apheresis kit

B.BRAUN - 04046963845773

H.E.L.P. ULTRAFILTER SMC 1.8 (US)
B.Braun Avitum AG
7210932
Not in Commercial Distribution

  • 04046963845773 ()
  • 04046964249693 ()

  • Area/Surface Area: 1.8 Square meter
7210932

  • Apheresis kit

B.BRAUN - 04046963847418

EMPTY BAG CONNECTION LINE (US)
B.Braun Avitum AG
7210934
In Commercial Distribution

  • 04046963847418 ()
  • 04046963847425 ()
7210934

  • Apheresis kit

B.BRAUN - 04046963845780

H.E.L.P. HEPARIN ADSORBER (US)
B.Braun Avitum AG
7210933
Not in Commercial Distribution

  • 04046963845780 ()
  • 04046964249709 ()
7210933

  • Apheresis kit

B.BRAUN - 04046963845766

H.E.L.P. PRECIPITATE FILTER (US)
B.Braun Avitum AG
7210931
Not in Commercial Distribution

  • 04046963845766 ()
  • 04046964249686 ()
7210931

  • Apheresis kit

H.E.L.P.® - 04046964156731

H.E.L.P. ACETATPUFFER HOT US / CA
B.Braun Avitum AG
4469
Not in Commercial Distribution

  • 04046964156731 ()
  • 04046964156724 ()

  • Volume : 4000.000 ML
  • Acidity (pH) : 4.850 PH
  • Acetic acid 99% : 6.820 GLI
  • Sodium acetate x 3 H2O : 27.220 GLI
4469

  • Apheresis kit

B.BRAUN - 04046963711177

EMPTY BAG FOR PRIMING SOLUTION FUTURA US
B.Braun Avitum AG
7210929
Not in Commercial Distribution

  • 04046963711177 ()
  • 04046964249655 ()
7210929

  • Apheresis kit

B.BRAUN - 04046963711160

DIALYSING LINE FUTURA (US)
B.Braun Avitum AG
7210928
Not in Commercial Distribution

  • 04046963711160 ()
  • 04046964249648 ()
7210928

  • Apheresis kit

B.BRAUN - 04046963711153

ARTERIAL LINE FUTURA (US)
B.Braun Avitum AG
7210927
Not in Commercial Distribution

  • 04046963711153 ()
  • 04046964249631 ()
7210927

  • Apheresis kit

B.BRAUN - 04046963711139

H.E.L.P.® Plasmat® Futura Treatment Kit
B.Braun Avitum AG
7210925
Not in Commercial Distribution

  • 04046963711139 ()
  • 04046964249624 ()
7210925

  • Apheresis kit

B.BRAUN - 04046964133534

HELP FUTURA SET WITH 4 FILTERS (US)
B.Braun Avitum AG
7211091
Not in Commercial Distribution

  • 04046964133534 ()
  • 04046964251153 ()
7211091

  • Apheresis kit

B.BRAUN - 04046964231834

HELP HEPARIN ADSORBER 400 US/CA
B.Braun Avitum AG
7211089
Not in Commercial Distribution

  • 04046964231834 ()
  • 04046964231841 ()
7211089

  • Apheresis kit

B.BRAUN - 04046964290169

HELP ACETATE BUFFER 4.85 US 3000ML
B.Braun Avitum AG
4113
Not in Commercial Distribution

  • 04046964290169 ()
  • 04046964041648 ()

  • Acidity (pH) : 4.850 PH
  • Volume : 3000.000 ML
4113

  • Apheresis kit

B.BRAUN - 04046964249679

EMPTY BAGS FOR DIALYSATE FUTURA (US)
B.Braun Avitum AG
7210930
Not in Commercial Distribution

  • 04046963711184 ()
  • 04046964249679 ()
  • 04046964249662 ()
7210930

  • Apheresis kit

B.BRAUN - 04046964319860

H.E.L.P. Heparin Sodium Solution 30 mL
B.Braun Avitum AG
7061188
Not in Commercial Distribution

  • 04046964319860 ()
  • 04030539195089 ()

  • Concentration (IU/ml) : 10000.000 IE3
  • Volume : 30.000 ML
7061188

  • Apheresis kit

H.E.L.P.® - 04046964699467

HELP HEPARIN 400,000 IU V 50/40ML US
B.Braun Avitum AG
7061192
In Commercial Distribution

  • 04046964699467 ()
  • 04046955348367 ()

  • Volume : 40.000 ML
  • Concentration (IU/ml) : 10000.000 IE3
7061192

  • Apheresis kit

H.E.L.P.® - 04046964696770

HELP ULTRAFILTER HIPS 20 US
B.Braun Avitum AG
7211101
Not in Commercial Distribution

  • 04046964696770 ()
  • 04046964696763 ()

  • Max TMP (mmHg) : 600.000 MHG
7211101

  • Apheresis kit

H.E.L.P.® - 04046964695865

HELP HOT FUTURA SET
B.Braun Avitum AG
7211094
Not in Commercial Distribution

  • 04046964695865 ()
  • 04046964695858 ()
7211094

  • Apheresis kit

Alinity - 00380740138783

Alinity h-series WATER PURIFICATION SYSTEM
Abbott GmbH
09P7101
In Commercial Distribution

  • 00380740138783 ()
09P7101

  • Deionization water purification system

Rika Plasma Bottle - 05020583213005

elabeling.terumobct.com
TERUMO BCT, INC.
21300
In Commercial Distribution

  • 35020583213006 ()
  • 05020583213005 ()


  • Apheresis kit
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