Urofoam®-2 Double-Sided Adhesive Foam Strip Box of 50 5200

GUDID 00792293052001

Urofoam®-2 double-sided adhesive foam strips are soft, pliable foam strips specifically designed for the unique application of male external catheters to the body and are suitable for use with both standard and self-adhering type catheters. They provide a comfortable, effective way to secure a male external catheter to the body. They are easy to apply and remove so when it comes time to change that catheter, it can be changed easily and quickly. It is recommended that a male external catheter be changed once a day to promote healthy skin, however, with the use or Urofoam® strips, a male external catheter can be held in place for up to three days—results may vary, but it's nice to know that when you need to depend on an adhesive strip, you can depend on Urofoam®.

UROCARE PRODUCTS, INC.

Skin surface device adhesive, non-sterile
Primary Device ID00792293052001
NIH Device Record Key6d81b0cb-72a0-4d55-a815-dd55c038bb5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrofoam®-2 Double-Sided Adhesive Foam Strip Box of 50
Version Model Number5200
Catalog Number5200
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Weight0.32 Pound
Device Size Text, specify0
Weight0.32 Pound
Device Size Text, specify0
Weight0.32 Pound
Device Size Text, specify0
Weight0.32 Pound
Device Size Text, specify0
Weight0.32 Pound
Device Size Text, specify0
Weight0.32 Pound
Device Size Text, specify0

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100792293052001 [Primary]

FDA Product Code

KGXTape And Bandage, Adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-30

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.