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

  • 10704411007623 ()
  • 40704411007624 ()
AS890K

  • Intermittent urethral catheterization kit
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 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. 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. 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. 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. 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. 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 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 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 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 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 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 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 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 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 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® 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 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 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 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 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 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® 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 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 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 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 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 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 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 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
TRAY,URETHRAL
MEDLINE INDUSTRIES, INC.
DYND18201A
In Commercial Distribution

  • 10884389533796 ()
  • 40884389533797 ()
DYND18201A

  • General surgical procedure kit, non-medicated, single-use
URETHRAL TRAY
MEDLINE INDUSTRIES, INC.
DYND18202B
In Commercial Distribution

  • 10884389867839 ()
  • 40884389867830 ()
DYND18202B

  • General surgical procedure kit, non-medicated, single-use
100% Silicone Foley Catheter Kit,2-Way
Cardinal Health, Inc.
8887606203
Not in Commercial Distribution

  • 20884521009759 ()
  • 10884521009752 ()

  • Catheter Gauge: 20 French
  • Total Volume: 5 Milliliter
8887606203

  • Indwelling urethral catheterization kit, adult
100% Silicone Foley Catheter Kit,2-Way
Cardinal Health, Inc.
8887606187
Not in Commercial Distribution

  • 20884521009742 ()
  • 10884521009745 ()

  • Total Volume: 5 Milliliter
  • Catheter Gauge: 18 French
8887606187

  • Indwelling urethral catheterization kit, adult
100% Silicone Foley Catheter Kit,2-Way
Cardinal Health, Inc.
8887606161
Not in Commercial Distribution

  • 20884521009735 ()
  • 10884521009738 ()

  • Catheter Gauge: 16 French
  • Total Volume: 5 Milliliter
8887606161

  • Indwelling urethral catheterization kit, adult
100% Silicone Foley Kit,14 Fr/Ch (4.7 mm), 5 mL, 2-Way Catheter
Cardinal Health, Inc.
8887606146
Not in Commercial Distribution

  • 20884521009728 ()
  • 10884521009721 ()

  • Total Volume: 5 Milliliter
  • Catheter Gauge: 14 French
8887606146

  • Indwelling urethral catheterization kit, adult
Closed Urethral Tray with Vinyl Catheter,1000 mL Bag, Prepping Components
Cardinal Health, Inc.
3450LF
Not in Commercial Distribution

  • 20884521009582 ()
  • 10884521009585 ()

  • Total Volume: 1000 Milliliter
  • Catheter Gauge: 14 French
3450LF

  • Indwelling urethral catheterization kit, adult
OPEN URETHRAL TRAY, VINYL CATHETER, 1000 ML BASIN, PVP, PREPPING COMPONENTS, 14 FR (4.7 MM)
Cardinal Health, Inc.
8887600073
In Commercial Distribution

  • 20884521009575 ()
  • 10884521009578 ()

  • Catheter Gauge: 14 French
8887600073

  • Indwelling urethral catheterization kit, adult
Open Urethral Tray with Red Rubber Catheter,Prepping Components
Cardinal Health, Inc.
8887600057
In Commercial Distribution

  • 20884521009568 ()
  • 10884521009561 ()

  • Catheter Gauge: 14 French
8887600057

  • Indwelling urethral catheterization kit, adult
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