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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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AMSure® Foley Insertion Tray - 10704411007616

AMSure® Foley Insertion Tray CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 1000 mL Outer Basin Tray 1 each Prefilled 10 mL Syringe of Sterile Water 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly NON-STERILE CONTENT: 1 pack BZK Swabsticks (3)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007617 ()
  • 10704411007616 ()
AS880K

  • Intermittent urethral catheterization kit

AMSure® Urethral Catheterization Tray - 10704411007609

AMSure® Urethral Catheterization Tray CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 14 Fr. Vinyl Catheter 1 each 1000 mL Outer Basin Tray 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 each 4 oz Specimen Cup NON-STERILE CONTENT: 1 pack BZK Swabsticks (3)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007600 ()
  • 10704411007609 ()
AS870K

  • Intermittent urethral catheterization kit

AMSure® Urethral Self Catheterization Kit 16Fr. - 10704411007593

AMSure® Urethral Self Catheterization Kit 16Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007594 ()
  • 10704411007593 ()
AS85016K

  • Intermittent urethral catheterization kit

AMSure® Urethral Self Catheterization Kit 14Fr. - 10704411007586

AMSure® Urethral Self Catheterization Kit 14Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007587 ()
  • 10704411007586 ()
AS85014K

  • Intermittent urethral catheterization kit

AMSure® Urethral Self Catheterization Kit 12Fr. - 10704411007579

AMSure® Urethral Self Catheterization Kit 12Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007570 ()
  • 10704411007579 ()
AS85012K

  • Intermittent urethral catheterization kit

AMSure® Urethral Self Catheterization Kit 10Fr. - 10704411007562

AMSure® Urethral Self Catheterization Kit 10Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007563 ()
  • 10704411007562 ()
AS85010K

  • Intermittent urethral catheterization kit

AMSure® Urethral Self Catheterization Kit 8Fr. - 10704411007555

AMSure® Urethral Self Catheterization Kit 8Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007556 ()
  • 10704411007555 ()
AS85008K

  • Intermittent urethral catheterization kit

AMSure® Pre-Connected Urethral Tray - 10704411007548

AMSure® Pre-Connected Urethral Tray 14 Fr. Red Rubber Urethral Catheter Pre-Connected to Drainage Bag 1 each 1200 mL Drainage Bag with Pre-Connected 14 Fr. Red Rubber Urethral Catheter CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each CSR Wrap 1 each Waterproof Absorbent Underpad 1 pair Pre-Cuffed Nitrile Gloves 1 each Fenestrated Drape 1 pack Package Sterile Lubricating Jelly 1 each 2 oz Specimen Container with ID Label NON-STERILE CONTENT: 1 pack BZK Swabsticks (3)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007549 ()
  • 10704411007548 ()
AS89214K

  • Intermittent urethral catheterization kit

AMSure® Pre-Connected Urethral Tray - 10704411007531

AMSure® Pre-Connected Urethral Tray 16 Fr. Red Rubber Urethral Catheter Pre-Connected to Drainage Bag CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 1200 mL Drainage Bag with Pre-Connected 16 Fr. Red Rubber Urethral Catheter 1 each CSR Wrap 1 each Waterproof Absorbent Underpad 1 pair Pre-Cuffed Nitrile Gloves 1 each Fenestrated Drape 1 pack Package Sterile Lubricating Jelly 1 each 2 oz Specimen Container with ID Label NON-STERILE CONTENT: 1 pack BZK Swabsticks (3)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007532 ()
  • 10704411007531 ()
AS89216K

  • Intermittent urethral catheterization kit

AMSure® Urethral Catheterization Tray - 10704411007524

AMSure® Urethral Catheterization Tray 14Fr CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Red Rubber Urethral Catheter 1 each 1000 mL Outer Basin Tray 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 each 4 oz Specimen Cup NON-STERILE CONTENT: 1 pack BZK Swabsticks (3)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007525 ()
  • 10704411007524 ()
AS87114K

  • Intermittent urethral catheterization kit

AMSure® Add-A-Foley Catheter Tray - 10704411007241

AMSure® Add-A-Foley Catheter Tray CONTENTS: One each 2000 mL Drainage bag with: Large anti-reflux chamber Universal hook hanger Bed sheet clamp T-valve drainage outlet Air vent AMSafe needleless sampling port
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007242 ()
  • 10704411007241 ()
AS89330

  • Intermittent urethral catheterization kit

AMSure® Foley Catheter Tray - 10704411003847

AMSure® Foley Catheter Tray Silicone Coated Latex Foley Catheter - 5mL Balloon, Inflate with 10mL sterile water. Contents: 2000mL Drainage Bag, Silicone Coated Latex Foley Catheter, Wrap, Drape, Fenestrated Drape, Catheter Lubricating Jelly Sachet, Nitrile Golves (2), Forceps, Rayon Balls (5), Povidone-Iodine Solution, 10mL Syringe with Pre-filled Sterile Water, Specimen Container, Lid and Label
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003848 ()
  • 10704411003847 ()
AS89318

  • Intermittent urethral catheterization kit

AMSure® Urethral Catheterization Tray - 10704411003779

AMSure® Urethral Catheterization Tray CONTENTS: 1 each 14Fr Vinyl Catheter, 1 each 1000mL Outer Basin Tray, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks, 1 each 4 oz Specimen Cup
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003770 ()
  • 10704411003779 ()
AS870

  • Intermittent urethral catheterization kit

AMSure® Urethral Self Catheterization Kit - 10704411003595

AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System CONTENTS: 1 Pre-lubricated PVC Urethral Catheter, 16" (40cm) Length, 1 1100ml Collection Bag with Insertion Tip, 3 Povidone-Iodine Swabsticks, 1 Benzalkonium Chloride Prep Pad, 2 Cuffed Vinyl Gloves, 1 Warerproof Underpad, 13" × 18" (340 × 450 mm), 1 Waste Disposal Bag, 1 Gauze Pad, 4" × 4" (100 × 100 mm)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003596 ()
  • 10704411003595 ()
AS85016

  • Intermittent urethral catheterization kit

AMSure® Urethral Self Catheterization Kit - 10704411003588

AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System CONTENTS: 1 Pre-lubricated PVC Urethral Catheter, 16" (40cm) Length, 1 1100ml Collection Bag with Insertion Tip, 3 Povidone-Iodine Swabsticks, 1 Benzalkonium Chloride Prep Pad, 2 Cuffed Vinyl Gloves, 1 Warerproof Underpad, 13" × 18" (340 × 450 mm), 1 Waste Disposal Bag, 1 Gauze Pad, 4" × 4" (100 × 100 mm)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003589 ()
  • 10704411003588 ()
AS85014

  • Intermittent urethral catheterization kit

AMSure® Urethral Self Catheterization Kit - 10704411003571

AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System CONTENTS: 1 Pre-lubricated PVC Urethral Catheter, 16" (40cm) Length, 1 1100ml Collection Bag with Insertion Tip, 3 Povidone-Iodine Swabsticks, 1 Benzalkonium Chloride Prep Pad, 2 Cuffed Vinyl Gloves, 1 Warerproof Underpad, 13" × 18" (340 × 450 mm), 1 Waste Disposal Bag, 1 Gauze Pad, 4" × 4" (100 × 100 mm)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003572 ()
  • 10704411003571 ()
AS85012

  • Intermittent urethral catheterization kit

AMSure® Urethral Self Catheterization Kit - 10704411003564

AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System CONTENTS: 1 Pre-lubricated PVC Urethral Catheter, 16" (40cm) Length, 1 1100ml Collection Bag with Insertion Tip, 3 Povidone-Iodine Swabsticks, 1 Benzalkonium Chloride Prep Pad, 2 Cuffed Vinyl Gloves, 1 Warerproof Underpad, 13" × 18" (340 × 450 mm), 1 Waste Disposal Bag, 1 Gauze Pad, 4" × 4" (100 × 100 mm)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003565 ()
  • 10704411003564 ()
AS85010

  • Intermittent urethral catheterization kit

AMSure® Urethral Self Catheterization Kit - 10704411003557

AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System CONTENTS: 1 Pre-lubricated PVC Urethral Catheter, 16" (40cm) Length, 1 1100ml Collection Bag with Insertion Tip, 3 Povidone-Iodine Swabsticks, 1 Benzalkonium Chloride Prep Pad, 2 Cuffed Vinyl Gloves, 1 Warerproof Underpad, 13" × 18" (340 × 450 mm), 1 Waste Disposal Bag, 1 Gauze Pad, 4" × 4" (100 × 100 mm)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003558 ()
  • 10704411003557 ()
AS85008

  • Intermittent urethral catheterization kit

AMSure® Foley Insertion Tray - 10704411002390

AMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray, 1 each Prefilled 30cc Syringe of Sterile Water, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411002391 ()
  • 10704411002390 ()
AS890

  • Intermittent urethral catheterization kit

AMSure® Foley Catheter Tray - 10704411005322

AMSure® Foley Catheter Tray Contents: 2000mL drainage bag, 100% Silicone Foley Catheter, Wrap, Drape, Fenestrated Drape, Catheter Lubricating Jelly Sachet, Nitrile Gloves (2), Forceps, Rayon Balls (5), Povidone-Indine Solution, 10mL Syringe with Pre-filled Sterile Water, Specimen Container, Lid and Label
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411005323 ()
  • 10704411005322 ()
AS89318S

  • Intermittent urethral catheterization kit

AMSure® Foley Catheter Tray - 10704411005315

AMSure® Foley Catheter Tray Contents: 2000mL drainage bag, 100% Silicone Foley Catheter, Wrap, Drape, Fenestrated Drape, Catheter Lubricating Jelly Sachet, Nitrile Gloves (2), Forceps, Rayon Balls (5), Povidone-Indine Solution, 10mL Syringe with Pre-filled Sterile Water, Specimen Container, Lid and Label
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411005316 ()
  • 10704411005315 ()
AS89316S

  • Intermittent urethral catheterization kit

AMSure® Foley Catheter Tray - 10704411005308

AMSure® Foley Catheter Tray Contents: 2000mL drainage bag, 100% Silicone Foley Catheter, Wrap, Drape, Fenestrated Drape, Catheter Lubricating Jelly Sachet, Nitrile Gloves (2), Forceps, Rayon Balls (5), Povidone-Indine Solution, 10mL Syringe with Pre-filled Sterile Water, Specimen Container, Lid and Label
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411005309 ()
  • 10704411005308 ()
AS89314S

  • Intermittent urethral catheterization kit

AMSure® Add-A-Foley Catheter Tray - 10704411005292

AMSure® Add-A-Foley Catheter Tray CONTENTS; 1 2000mL Drainage bag, 1 Wrap, 1 Drape, 2 Nitrile Gloves, 1 Fenestrate Drape, 1 Pkg. Povidone-Iodine Solution, 5 Rayon Balls, 1 Catheter Lubricating Jelly Sachet, 1 Plastic Forceps, 1 Specimen Container and Label, 1 10mL Syringe with Pre-filled Sterile Water
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411005293 ()
  • 10704411005292 ()
AS89300

  • Intermittent urethral catheterization kit

AMSure® Foley Catheter Tray - 10704411003830

AMSure® Foley Catheter Tray Silicone Coated Latex Foley Catheter - 5mL Balloon, Inflate with 10mL sterile water. Contents: 2000mL Drainage Bag, Silicone Coated Latex Foley Catheter, Wrap, Drape, Fenestrated Drape, Catheter Lubricating Jelly Sachet, Nitrile Golves (2), Forceps, Rayon Balls (5), Povidone-Iodine Solution, 10mL Syringe with Pre-filled Sterile Water, Specimen Container, Lid and Label
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003831 ()
  • 10704411003830 ()
AS89316

  • Intermittent urethral catheterization kit

AMSure® Foley Catheter Tray - 10704411003823

AMSure® Foley Catheter Tray Silicone Coated Latex Foley Catheter - 5mL Balloon, Inflate with 10mL sterile water. Contents: 2000mL Drainage Bag, Silicone Coated Latex Foley Catheter, Wrap, Drape, Fenestrated Drape, Catheter Lubricating Jelly Sachet, Nitrile Golves (2), Forceps, Rayon Balls (5), Povidone-Iodine Solution, 10mL Syringe with Pre-filled Sterile Water, Specimen Container, Lid and Label
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003824 ()
  • 10704411003823 ()
AS89314

  • Intermittent urethral catheterization kit

AMSure® Pre-Connected Urethral Tray - 10704411003816

AMSure® Pre-Connected Urethral Tray Red Rubber Urethral Catheter Pre-Connected to Drainage Bag. Contents: 1200ml Drainage Bag with Pre-Connected 14 Fr Red Rubber Urethral Catheter, CSR Wrap, Waterproof Absorbent Underpad, Pre-Cuffed Nitrile Gloves (2), Fenestrated Drape, Povidone-Iodine Swabsticks (3), Package Sterile Lubricating Jelly, 2oz Specimen Container with ID Label
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003817 ()
  • 10704411003816 ()
AS89214R

  • Intermittent urethral catheterization kit

AMSure® Urethral Catheterization Tray - 10704411003809

AMSure® Urethral Catheterization Tray CONTENTS: 1 each Red Rubber Urethral Catheter, 1 each 1000mL Outer Basin Tray, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks, 1 each 4 oz Specimen Cup
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003800 ()
  • 10704411003809 ()
AS87118

  • Intermittent urethral catheterization kit

AMSure® Urethral Catheterization Tray - 10704411003793

AMSure® Urethral Catheterization Tray CONTENTS: 1 each Red Rubber Urethral Catheter, 1 each 1000mL Outer Basin Tray, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks, 1 each 4 oz Specimen Cup
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003794 ()
  • 10704411003793 ()
AS87116

  • Intermittent urethral catheterization kit

AMSure® Urethral Catheterization Tray - 10704411003786

AMSure® Urethral Catheterization Tray CONTENTS: 1 each Red Rubber Urethral Catheter, 1 each 1000mL Outer Basin Tray, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks, 1 each 4 oz Specimen Cup
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411003787 ()
  • 10704411003786 ()
AS87114

  • Intermittent urethral catheterization kit

AMSure® Foley Insertion Tray - 10704411002383

AMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray, 1 each Prefilled 10cc Syringe of Sterile Water, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411002384 ()
  • 10704411002383 ()
AS880

  • Intermittent urethral catheterization kit
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