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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 Catheter Tray - 10704411019664

"•100% Silicone Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019665 ()
  • 10704411019664 ()
AS89914S

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019626

"•Hydrophilic Latex Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019627 ()
  • 10704411019626 ()
AS89418H

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019619

"•Hydrophilic Latex Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019610 ()
  • 10704411019619 ()
AS89416H

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019602

"•Hydrophilic Latex Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019603 ()
  • 10704411019602 ()
AS89414H

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019596

"•100% Silicone Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019597 ()
  • 10704411019596 ()
AS89418S

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019572

"•100% Silicone Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019573 ()
  • 10704411019572 ()
AS89414S

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019558

•Silicone Coated Latex Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019559 ()
  • 10704411019558 ()
AS89416

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Insertion Tray - 10704411008033

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 1 pack PVP Swabsticks (3)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411008034 ()
  • 10704411008033 ()
AS890-02

  • Intermittent urethral catheterization kit

AMSure® Foley Insertion Tray - 10704411008026

AMSure® Foley Insertion Tray CONTENTS: Color: Pantone 293c 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 1 pack PVP Swabsticks (3)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411008027 ()
  • 10704411008026 ()
AS880-02

  • Intermittent urethral catheterization kit

AMSure® Urethral Catheterization Tray 15Fr - 10704411007630

AMSure® Urethral Catheterization Tray 15Fr 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; 1 each 4 oz Specimen Cup; 1 pack PVP swabstick(3)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007631 ()
  • 10704411007630 ()
AS87115

  • Intermittent urethral catheterization kit

AMSure® Foley Insertion Tray - 10704411007623

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 - 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® 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® 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 - 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® 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 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

AMSure® Foley Catheter Tray - 10704411019671

"•100% Silicone Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019672 ()
  • 10704411019671 ()
AS89916S

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019657

"•Silicone Coated Latex Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019658 ()
  • 10704411019657 ()
AS89918

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019640

"•Silicone Coated Latex Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019641 ()
  • 10704411019640 ()
AS89916

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019633

"•Silicone Coated Latex Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019634 ()
  • 10704411019633 ()
AS89914

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019589

"•100% Silicone Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019580 ()
  • 10704411019589 ()
AS89416S

  • Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray - 10704411019565

"•Silicone Coated Latex Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)"
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411019566 ()
  • 10704411019565 ()
AS89418

  • Indwelling urethral catheterization kit, adult
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