Urofoam®-1 Single-Sided Adhesive Foam Strip Box of 50 5100

GUDID 00792293051004

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®.

UROCARE PRODUCTS, INC.

Skin surface device adhesive, non-sterile Skin surface device adhesive, non-sterile Skin surface device adhesive, non-sterile Skin surface device adhesive, non-sterile Skin surface device adhesive, non-sterile Skin surface device adhesive, non-sterile Skin surface device adhesive, non-sterile Skin surface device adhesive, non-sterile Skin surface device adhesive, non-sterile

• Primary Device ID: 00792293051004
• NIH Device Record Key: f15d6658-4655-49d0-b38d-88f54c43648f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urofoam®-1 Single-Sided Adhesive Foam Strip Box of 50
• Version Model Number: 5100
• Catalog Number: 5100
• Company DUNS: 070637129
• Company Name: UROCARE PRODUCTS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM
• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM
• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM
• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM
• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM
• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM
• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM
• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM
• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM

Device Dimensions

• Weight: 0.18 Pound
• Weight: 0.18 Pound
• Weight: 0.18 Pound
• Weight: 0.18 Pound
• Device Size Text, specify: 0
• Weight: 0.18 Pound
• Device Size Text, specify: 0
• Weight: 0.18 Pound
• Device Size Text, specify: 0
• Weight: 0.18 Pound
• Device Size Text, specify: 0
• Weight: 0.18 Pound
• Device Size Text, specify: 0
• Weight: 0.18 Pound
• Device Size Text, specify: 0
• Weight: 0.18 Pound

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 * Store in cool, dark, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00792293051004 [Primary]

FDA Product Code

• NNX: Device, Incontinence, Urosheath Type, Non-Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-30

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