Urofoam®-1 Single-Sided Adhesive Foam Strip Box of 50

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name: Urofoam®-1 Single-Sided Adhesive Foam Strip Box of 50 FDA UDI
Generic Name: Skin surface device adhesive FDA UDI
Device Name: Urofoam®-1 single-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®. FDA UDI
Model / Reference: 5100 FDA UDI
Description: Urofoam®-1 single-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®. FDA UDI

Identifiers

Catalog Number: 5100 FDA UDI
Primary DI / UDI-DI: 00792293051004 FDA UDI
FDA Product Code: NNX FDA UDI
KGX FDA UDI
GMDN Term: Skin surface device adhesive FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5250 FDA UDI
880.5240 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

Yes

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Dimensions & Sizes

Size: Weight — 0.18 Pound FDA UDI

Category: Urinary incontinence penis sheath/port, single-use Skin surface device adhesive

Urofoam®-1 Single-Sided Adhesive Foam Strip Box of 50 by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Urocare Products, Inc.

Sources (1)

FDA UDI f15d6658-4655-49d0-b38d-88f54c43648f 37 fields · synced Jun 1, 2026