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.
00792293055002
GS1

1
070637129 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

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.
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.
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.
Active false
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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Weight: 0.004 Pound
Height: 2.25 Inch
Depth: 0.1 Inch
Width: 2.25 Inch
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Device Record Status

75567a13-2eae-435c-8c08-3ef721bfbe65
December 08, 2022
7
June 01, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
909-621-6013
CUST.SUPPORT@UROCARE.COM
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