DEVICE: Uro-Prep® Protective Skin Barrier Wipes (Box of 50) (00792293055002)
Device Identifier (DI) Information
Uro-Prep® Protective Skin Barrier Wipes (Box of 50)
5500
In Commercial Distribution
5500
UROCARE PRODUCTS, INC.
5500
In Commercial Distribution
5500
UROCARE PRODUCTS, INC.
PROTECTIVE, BARRIER, DRESSING, SKIN, PADS, WIPES, SACHETTE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE
Uro-Prep® Protective Barrier has been specifically formulated to create a protective barrier between delicate, sensitive skin and aggressive adhesives. They can be used under all types of medical adhesives. Packaged in a small, convenient wipe, Uro-Prep® skin barrier wipes are the perfect solution to aid in the protection of delicate skin that has become sensitive to repeated use of medical adhesives; especially, those used to secure male external urinary catheters and urinary or ostomy appliances. Uro-Prep® protective skin barrier wipes are alcohol based which are easy to apply, safe, effective. It is recommended that a male external catheter be changed once a day to promote healthy skin and using Uro-Prep® protective skin barrier wipes before applying a male external catheter, urinary or ostomy appliance will help protect skin from any aggressive adhesives used with their application.
Key Features:
• Alcohol Based—Dries quickly for fast use.
• Many Uses—Can be used under all types of medical adhesives
• Convenient—Travel size pads are small and easy to use
• Soap & Water Clean-Up—Just wash, rinse and dry
• Suitable for Hospital, Long-Term Care and Home Use
• Reduces Adhesive Removal Trauma
• Environmentally Friendly—Does not contain ozone-depleting chloro-fluorocarbons
• Convenient Packaging—Use only what you need so there's less waste
Note: For external use only.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46206 | Dry skin moisture barrier dressing |
A substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. After application, this device cannot be reused.
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Active | false |
34929 | Urinary incontinence penis sheath/port, single-use |
A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
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Active | false |
10035 | Skin surface device adhesive |
A 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.
|
Active | false |
60494 | Patient medical adhesive remover |
A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EXE | Protector, Ostomy |
KGX | Tape And Bandage, Adhesive |
NNX | Device, Incontinence, Urosheath Type, Non-Sterile |
EZR | Cement, Stomal Appliance, Ostomy |
KOX | Solvent, Adhesive Tape |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 0.004 Pound |
Height: 2.25 Inch |
Depth: 0.1 Inch |
Width: 2.25 Inch |
Device Record Status
75567a13-2eae-435c-8c08-3ef721bfbe65
December 08, 2022
7
June 01, 2018
December 08, 2022
7
June 01, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
909-621-6013
CUST.SUPPORT@UROCARE.COM
CUST.SUPPORT@UROCARE.COM