FDA.reportPublic FDA data

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

Primary DI
00792293052001
Brand
Urofoam®-2 Double-Sided Adhesive Foam Strip Box of 50
Company
UROCARE PRODUCTS, INC.
Model
5200
Catalog number
5200
Device description
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®.
Published
2018-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive
NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792293052001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293052001007922930520017922930520010792293052001

GMDN Terms#

Term, Definition table
TermDefinition
Skin surface device adhesive, non-sterileA non-sterile substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Weight0.32Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00 Store in cool, dark, dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
909-621-6013CUST.SUPPORT@UROCARE.COM

Regulatory Flags#

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792293063106"Urocare® Fabric Foley® Catheter/Tubing Strap Standard 18"""631063102018-05-30
00792293063113"Urocare® Fabric Foley® Catheter/Tubing Strap Arm 14"""631163112018-05-30
00792293063120"Urocare® Fabric Foley® Catheter/Tubing Strap Large 22"""631263122018-05-30
00792293063137"Urocare® Fabric Foley® Catheter/Tubing Strap Abdominal 34"""631363132018-05-30
00792293301246Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm5301245301242025-01-01
00792293301284Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm5301285301282025-01-01
00792293301314Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm5301315301312025-01-01
00792293301352Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm5301355301352025-01-01
00792293301406Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm5301405301402025-01-01
00792293043993Urocare® Male Urinal Kit, Laced Closue, Small439943992018-04-11
00792293044006Urocare® Male Urinal Kit, Laced Closue, Medium440044002018-04-11
00792293044013Urocare® Male Urinal Kit, Laced Closue, Large440144012018-04-11
00792293044020Urocare® Male Urinal Kit, Velcro® Closue, Small440244022018-04-11
00792293044037Urocare® Male Urinal Kit, Velcro® Closue, Large440344032018-04-11
00792293044044Urocare® Male Urinal Kit, Laced Closue, Extra-Large440444042018-04-11
00792293044204"Urocare® Male Urinal Suspensory Garment, Laced Closure, Small 26"" to 38"" Waist"442044202018-04-12
00792293044211"Urocare® Male Urinal Suspensory Garment, Laced Closure, Large 38"" to 46"" Waist"442144212018-04-12
00792293062000Urocare® Latex-Free Anti-Snoring Strap620062002018-05-29
00792293944023Urocare® Male Urinal System, Velcro® Closue, Small94402944022018-04-11
00792293055002Uro-Prep® Protective Skin Barrier Wipes (Box of 50)550055002018-06-01

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