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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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DISC, WAFER, DRESSING, ADHESIVE, FOAM, OSTOMY, STOMA, TRACHEOSTOMY, VOICE RESTORATION, SPEECH, VALVE Tracho-Foam® adhesive foam discs are soft, pliable foam discs specifically designed for the unique bonding applications of appliances to the skin and are suitable for securing valve housings of voice restoration systems to the body. With adhesive coated on both sides, they provide a comfortable, air-tight seal that conforms to the irregular contours of the stoma and eliminate hissing a side effect often found in other thinner or less flexible products. Key Features: • Ensolite Foam—Hypo-Allergenic • Closed-Cell Foam Structure—for an air-tight seal that eliminates hissing. • Soft and Pliable—Easily conforms to irregular contours of the body. • Perspiration resistant—It retains it's adhesive qualities even when sweating. • Easy to apply and Remove—Just peel 'n' Stick to apply, peel back to remove. If the disc is difficult to remove, Urocare® Adhesive Remover Pads may be used to soften the adhesive and assist in the removal of the disc. They contain a non-toxic, citrus-based adhesive remover that may also be used to remove most types of medical adhesive or adhesive residue from skin and appliances or in preparation for use of a new disc. Most medical grade adhesive removers will work basically in the same manner; however, consult your doctor or speech therapist to decide the best product for you and how to use it safely. For more information—see Urocare® Adhesive Remover Pads (#5600). In the event of skin that has become sensitive to aggressive medical adhesives, Urocare® has developed Uro-Prep® a protective skin barrier wipe for used under all types of medical adhesives. They protect delicate, sensitive skin from aggressive adhesives often used in conjunction with urinary or ostomy appliances. Uro-Prep® wipes are safe, effective, and for external use only. For more information—see Uro-Prep® (#5500).
UROCARE PRODUCTS, INC.
5300
In Commercial Distribution

  • 00792293053008 ()

  • Outer Diameter: 2.25 Inch
  • Lumen/Inner Diameter: 1.0 Inch
  • Height: 0.13 Inch
  • Standard
  • Weight: 0.002 Pound
5300

  • Tracheostomy tube dressing
  • Tracheostomy tube speech valve
  • Intestinal ostomy base plate, concave
  • Skin surface device adhesive
URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, LARGE 46" TO 54" (117CM TO 137CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94404 & #4404.
UROCARE PRODUCTS, INC.
4423
In Commercial Distribution

  • 00792293044235 ()

  • 117cm to 137cm Waist
  • 46" to 54" Wasit
  • Weight: 0.20 Pound
4423

  • Penis/scrotum wearable urinal
URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, UNIVERSAL 26" TO 46" (66CM TO 117CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94403, #94402, #4403 & #4402.
UROCARE PRODUCTS, INC.
4420
In Commercial Distribution

  • 00792293044228 ()

  • Weight: 0.20 Pound
  • 26" to 46" Wasit
  • 66cm to 117cm Waist
4420

  • Penis/scrotum wearable urinal
URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, LARGE 38" TO 46" (97CM TO 117CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94401 & #4401.
UROCARE PRODUCTS, INC.
4421
Not in Commercial Distribution

  • 00792293044211 ()

  • Weight: 0.18 Pound
  • 38" to 46" Wasit
  • 97cm to 117cm Waist
4421

  • Penis/scrotum wearable urinal
URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, SMALL 26" TO 38" (66CM TO 97CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94400, #4400 & #4399.
UROCARE PRODUCTS, INC.
4420
Not in Commercial Distribution

  • 00792293044204 ()

  • 66cm to 97cm Waist
  • 26" to 38" Wasit
  • Weight: 0.16 Pound
4420

  • Penis/scrotum wearable urinal
URINAL, SHEATH, MALE, URINE COLLECTION, LATEX, REUSABLE, LARGE 7" (18CM), 9 OZ (270 ML) Replacement sheath for Urocare Male Urinal systems and kits #94404, #94403 & #4401 & 4400. Includes: 1 Standard Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
4410
In Commercial Distribution

  • 00792293044105 ()

  • Weight: 0.08 Pound
  • Total Volume: 270 Milliliter
  • Total Volume: 9 Fluid Ounce
  • Length: 7 Inch
  • 20mm to 40mm I.D. (Inner Sheath)
  • Outer Diameter: 3.38 Inch
4410

  • Penis/scrotum wearable urinal
URINAL, SHEATH, MALE, URINE COLLECTION, LATEX, REUSABLE, SMALL 4" (10CM), 4 OZ (118 ML) Replacement sheath for Urocare Male Urinal systems and kits #94399, #94402 & #4399. Includes: 1 Standard Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
4409
In Commercial Distribution

  • 00792293044099 ()

  • Length: 4 Inch
  • Total Volume: 4 Fluid Ounce
  • Total Volume: 118 Milliliter
  • Weight: 0.06 Pound
  • Outer Diameter: 3.38 Inch
  • 20mm to 40mm I.D. (Inner Sheath)
4409

  • Penis/scrotum wearable urinal
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, LARGE Contains: 1 Male Urinal Garment Velcro Closure Universal #4422, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg Bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
4403
In Commercial Distribution

  • 00792293044037 ()

  • Total Volume: 270 Milliliter
  • Total Volume: 9 Fluid Ounce
  • Depth: 1.63 Inch
  • Weight: 0.45 Pound
  • Width: 5.63 Inch
  • Height: 9.25 Inch
  • Circumference: 40 Millimeter
  • Lumen/Inner Diameter: 20 Millimeter
4403

  • Penis/scrotum wearable urinal
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, SMALL Contains: 1 Male Urinal Garment Velcro Closure Universal #4422, 1 Male Urinal Sheath Small #4409, 1 Male Urinal to Latex Leg Bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
4402
In Commercial Distribution

  • 00792293044020 ()

  • Depth: 1.63 Inch
  • Lumen/Inner Diameter: 20 Millimeter
  • Total Volume: 4 Fluid Ounce
  • Circumference: 40 Millimeter
  • Total Volume: 118 Milliliter
  • Height: 9.25 Inch
  • Width: 5.63 Inch
  • Weight: 0.45 Pound
4402

  • Penis/scrotum wearable urinal
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, LARGE Contains: 1 Male Urinal Garment Laced Closure Large #4421, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
4401
Not in Commercial Distribution

  • 00792293044013 ()

  • Depth: 1.63 Inch
  • Weight: 0.45 Pound
  • Width: 5.63 Inch
  • Height: 9.25 Inch
  • Total Volume: 270 Milliliter
  • Circumference: 40 Millimeter
  • Total Volume: 9 Fluid Ounce
  • Lumen/Inner Diameter: 20 Millimeter
4401

  • Penis/scrotum wearable urinal
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