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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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TRUWAVE, VAMP - 07460691959521

PRESSURE MONITORING SET
Edwards Lifesciences LLC
T005050M
In Commercial Distribution

  • 57460691959526 ()
  • 07460691959521 ()

  • Volume 3 cc Length 235 cm
T005050M

  • Invasive-pressure external transducer, single-use
  • Arterial blood sampling kit

TRUWAVE X 3 (3 CC)/VAMP PLUS (215 CM) - 07460691959491

PRESSURE MONITORING SET
Edwards Lifesciences LLC
T100671M
In Commercial Distribution

  • 57460691959496 ()
  • 07460691959491 ()

  • Volume 3 cc, length 215 cm
T100671M

  • Invasive-pressure external transducer, single-use
  • Arterial blood sampling kit

TRUWAVE, VAMP PLUS - 07460691959477

PRESSURE MONITORING SET
Edwards Lifesciences LLC
T001691M
In Commercial Distribution

  • 57460691959472 ()
  • 07460691959477 ()

  • Volume 3 cc, Length 215 cm
T001691M

  • Invasive-pressure external transducer, single-use
  • Arterial blood sampling kit

NON-DEHP, SINGLE DPT LINE WITH VAMP JR RESERVOIR AND LASS - 07460691960572

PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXVJ050M
In Commercial Distribution

  • 07460691960572 ()

  • Volume 3 cc, Length 30 cm
PXVJ050M

  • Arterial blood sampling kit

Combo Kits - 00690103210828

Pressure Monitoring Set
Edwards Lifesciences LLC
PXVJL10014
In Commercial Distribution

  • 50690103210823 ()
  • 00690103210828 ()

  • Volume 3 cc; Length 28 inches
PXVJL10014

  • Arterial blood sampling kit

AMSure ® Foley Catheters Tray - 10704411014690

400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 18 Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411014691 ()
  • 10704411014690 ()
AS89818S

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use

AMSure ® Foley Catheters Tray - 10704411014683

400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 16 Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411014684 ()
  • 10704411014683 ()
AS89816S

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use

AMSure ® Foley Catheters Tray - 10704411014676

400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 14 Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411014677 ()
  • 10704411014676 ()
AS89814S

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use

AMSure ® Foley Catheters Tray - 10704411014669

400mL. Urine Meter attached to 2600mL drainage bag Hydrophilic Latex Foley Catheter 5 cc Balloon 18 Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411014660 ()
  • 10704411014669 ()
AS89818H

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use

AMSure ® Foley Catheters Tray - 10704411014652

400mL. Urine Meter attached to 2600mL drainage bag Hydrophilic Latex Foley Catheter 5 cc Balloon 16 Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411014653 ()
  • 10704411014652 ()
AS89816H

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use
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