Tracho-Foam® Double-Sided Adhesive Foam Disc, Standard 2.25" OD (Box of 30) 5300

GUDID 00792293053008

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.

Tracheostomy tube dressing, sterile Tracheostomy tube dressing, sterile Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing Tracheostomy tube dressing
Primary Device ID00792293053008
NIH Device Record Key4f9b752e-8f22-4fcc-940b-7f0bade0f273
Commercial Distribution StatusIn Commercial Distribution
Brand NameTracho-Foam® Double-Sided Adhesive Foam Disc, Standard 2.25" OD (Box of 30)
Version Model Number5300
Catalog Number5300
Company DUNS070637129
Company NameUROCARE PRODUCTS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM
Phone909-621-6013
EmailCUST.SUPPORT@UROCARE.COM

Device Dimensions

Weight0.002 Pound
Weight0.002 Pound
Weight0.002 Pound
Weight0.002 Pound
Weight0.002 Pound
Weight0.002 Pound
Weight0.002 Pound
Weight0.002 Pound
Weight0.002 Pound
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound
Outer Diameter2.25 Inch
Lumen/Inner Diameter1 Inch
Height0.13 Inch
Device Size Text, specify0
Weight0.002 Pound

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dark, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100792293053008 [Primary]

FDA Product Code

EZRCement, Stomal Appliance, Ostomy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-23
Device Publish Date2018-06-01

Devices Manufactured by UROCARE PRODUCTS, INC.

00792293781802 - Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags hav
00792293781819 - Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags ha
00792293783202 - Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags ha
00792293783219 - Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags h
00792293791801 - Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags hav
00792293791818 - Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags ha
00792293793201 - Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags ha
00792293793218 - Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags h
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.