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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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B.BRAUN - 04046964231834

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

  • 04046964231834 ()
  • 04046964231841 ()
7211089

  • Apheresis kit

Rika Plasma Bottle - 05020583213005

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

  • 35020583213006 ()
  • 05020583213005 ()


  • Apheresis kit

Rika Plasma Separation Set - 05020583212008

elabeling.terumobct.com
TERUMO BCT, INC.
21200
In Commercial Distribution

  • 35020583212009 ()
  • 05020583212008 ()


  • Apheresis kit

Alinity - 00380740138783

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

  • 00380740138783 ()
09P7101

  • Deionization water purification system

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

PowerFlow - 00801741136641

PowerFlow IV Port Access System, 16G
Bard Access Systems, Inc.
AIV16
In Commercial Distribution

  • 20801741136645 ()
  • 10801741136648 ()
  • 00801741136641 ()

  • Length: 1.77 Inch
  • Needle Gauge: 16 Gauge
AIV16

  • Apheresis kit

PowerFlow - 00801741136634

PowerFlow IV Port Access System, 14G
Bard Access Systems, Inc.
AIV14
In Commercial Distribution

  • 10801741136631 ()
  • 00801741136634 ()
  • 20801741136638 ()

  • Needle Gauge: 14 Gauge
  • Length: 1.75 Inch
AIV14

  • Apheresis kit

PowerFlow, ChronoFlex - 00801741129438

PowerFlow 9.6Fr ChronoFlex Implantable Apheresis IV Port Intermediate Kit
Bard Access Systems, Inc.
A710962
In Commercial Distribution

  • 10801741129435 ()
  • 00801741129438 ()

  • Catheter Gauge: 9.6 French
  • Length: 45 Centimeter
A710962

  • Apheresis kit

InQwire® - 00884450021637

No Description
Merit Medical Systems, Inc.
00884450021637
In Commercial Distribution

  • 10884450021634 ()
  • 00884450021637 ()

  • Configuration-Standard J 3.0 mm Tip Exchange
  • Tip Shape-3 mm J-Tip
  • Length-260 cm (102")
  • Tip Shape-3 mm J-Tip; Configuration-Standard J 3.0 mm Tip Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102")
  • Length-260 cm (102"); Configuration-Standard J 3.0 mm Tip Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102")
IQR35F260J3/B

  • Cardiac/peripheral vascular guidewire, single-use

Single Use Ureteral Access Sheath - 06936534304267

No Description
Zhejiang Chuangxiang Medical Technology Co., LTD.
MD-B-AS-1055
In Commercial Distribution

  • 06936534304267 ()


  • Ureteral introduction sheath

Single Use Ureteral Access Sheath - 06936534304250

No Description
Zhejiang Chuangxiang Medical Technology Co., LTD.
MD-B-AS-1045
In Commercial Distribution

  • 06936534304250 ()


  • Ureteral introduction sheath

Porges Coloplast - 03600040310892

Retrace Ureteral Accesss Sheath 35cm
Coloplast A/S
ACXL12
In Commercial Distribution

  • 03600040310892 ()

  • Catheter Gauge: 14 French
  • Catheter Gauge: 12 French
ACXL12

  • Ureteral introduction sheath

Porges Coloplast - 03600040308219

Retrace Ureteral Accesss Sheath 45cm
Coloplast A/S
AXXL12
In Commercial Distribution

  • 03600040308219 ()

  • Catheter Gauge: 14 French
  • Catheter Gauge: 12 French
AXXL12

  • Ureteral introduction sheath

Porges Coloplast - 03600040280560

Ureteral Accesss Sheath 45cm
Coloplast A/S
AXXS12
Not in Commercial Distribution

  • 03600040280560 ()

  • Catheter Gauge: 14 French
  • Catheter Gauge: 12 French
AXXS12

  • Ureteral introduction sheath

Porges Coloplast - 03600040280539

Ureteral Accesss Sheath 45cm
Coloplast A/S
AXXS10
Not in Commercial Distribution

  • 03600040280539 ()

  • Catheter Gauge: 12 French
  • Catheter Gauge: 10 French
AXXS10

  • Ureteral introduction sheath

Porges Coloplast - 03600040280508

Ureteral Accesss Sheath 35cm
Coloplast A/S
ACXS12
Not in Commercial Distribution

  • 03600040280508 ()

  • Catheter Gauge: 12 French
  • Catheter Gauge: 14 French
ACXS12

  • Ureteral introduction sheath

Porges Coloplast - 03600040280478

Ureteral Accesss Sheath 35cm
Coloplast A/S
ACXS10
Not in Commercial Distribution

  • 03600040280478 ()

  • Catheter Gauge: 10 French
  • Catheter Gauge: 12 French
ACXS10

  • Ureteral introduction sheath

Porges Coloplast - 03600040277508

Retrace Ureteral Accesss Sheath 45cm
Coloplast A/S
AXXL10
In Commercial Distribution

  • 03600040277508 ()

  • Catheter Gauge: 10 French
  • Catheter Gauge: 12 French
AXXL10

  • Ureteral introduction sheath

ReTrace - 03600040995365

No Description
Coloplast A/S
AXXL12
In Commercial Distribution

  • 03600040995389 ()
  • 03600040995372 ()
  • 03600040995365 ()

  • Sheath Length - cm 45
  • Sheath Inner Diameter - CH/FR 12
  • Sheath Outer Diameter - CH/FR 14
AXXL12

  • Ureteral introduction sheath

ReTrace - 03600040995334

No Description
Coloplast A/S
AXXL10
In Commercial Distribution

  • 03600040995341 ()
  • 03600040995334 ()
  • 03600040995358 ()

  • Sheath Length - cm 45
  • Sheath Outer Diameter - CH/FR 12
  • Sheath Inner Diameter - CH/FR 10
AXXL10

  • Ureteral introduction sheath

ReTrace - 03600040995303

No Description
Coloplast A/S
ASXL12
In Commercial Distribution

  • 03600040995310 ()
  • 03600040995303 ()
  • 03600040995327 ()

  • Sheath Outer Diameter - CH/FR 14
  • Sheath Inner Diameter - CH/FR 12
  • Sheath Length - cm 28
ASXL12

  • Ureteral introduction sheath

ReTrace - 03600040995273

No Description
Coloplast A/S
ASXL10
In Commercial Distribution

  • 03600040995280 ()
  • 03600040995273 ()
  • 03600040995297 ()

  • Sheath Outer Diameter - CH/FR 12
  • Sheath Length - cm 28
  • Sheath Inner Diameter - CH/FR 10
ASXL10

  • Ureteral introduction sheath

ReTrace - 03600040995242

No Description
Coloplast A/S
ALXL12
In Commercial Distribution

  • 03600040995259 ()
  • 03600040995242 ()
  • 03600040995266 ()

  • Sheath Outer Diameter - CH/FR 14
  • Sheath Inner Diameter - CH/FR 12
  • Sheath Length - cm 55
ALXL12

  • Ureteral introduction sheath

ReTrace - 03600040995211

No Description
Coloplast A/S
ALXL10
In Commercial Distribution

  • 03600040995235 ()
  • 03600040995228 ()
  • 03600040995211 ()

  • Sheath Length - cm 55
  • Sheath Inner Diameter - CH/FR 10
  • Sheath Outer Diameter - CH/FR 12
ALXL10

  • Ureteral introduction sheath

ReTrace - 03600040995181

No Description
Coloplast A/S
ACXL12
In Commercial Distribution

  • 03600040995198 ()
  • 03600040995181 ()
  • 03600040995204 ()

  • Sheath Length - cm 35
  • Sheath Outer Diameter - CH/FR 14
  • Sheath Inner Diameter - CH/FR 12
ACXL12

  • Ureteral introduction sheath

ReTrace - 03600040995150

No Description
Coloplast A/S
ACXL10
In Commercial Distribution

  • 03600040995167 ()
  • 03600040995150 ()
  • 03600040995174 ()

  • Sheath Outer Diameter - CH/FR 12
  • Sheath Length - cm 35
  • Sheath Inner Diameter - CH/FR 10
ACXL10

  • Ureteral introduction sheath

Porges Coloplast - 03600040322758

RETRACE® Ureteral Access Sheath, inner diameter CH FR 12, outer diameter CH FR 14, length 55 cm
Coloplast A/S
ALXL12
In Commercial Distribution

  • 03600040322758 ()

  • Catheter Gauge: 12 French
  • Catheter Gauge: 14 French
ALXL12

  • Ureteral introduction sheath

Porges Coloplast - 03600040322727

RETRACE® Ureteral Access Sheath, inner diameter CH FR 10, outer diameter CH FR 12, length 55 cm
Coloplast A/S
ALXL10
In Commercial Distribution

  • 03600040322727 ()

  • Catheter Gauge: 12 French
  • Catheter Gauge: 10 French
ALXL10

  • Ureteral introduction sheath
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