DEVICE: Urocare® Adhesive Remover Pads (Box of 50) (00792293056009)

Device Identifier (DI) Information

Urocare® Adhesive Remover Pads (Box of 50)
5600
In Commercial Distribution
5600
UROCARE PRODUCTS, INC.
00792293056009
GS1

1
070637129 *Terms of Use
ADHESIVE REMOVER, PADS, WIPES, SACHETTE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, NON-FLAMMABLE Urocare® adhesive remover has been specifically formulated for dissolving and removing unwanted adhesive or adhesive residue from urinary and ostomy appliances, tens units, monitoring electrodes, skin and can even be used for the removal of tar. Packaged in a small, convenient wipe, Urocare® adhesive remover pads are the perfect solution to aid in the removal of adhesive residue left behind by male external catheters. They may be used to soften the adhesive of double-sided adhesive foam strips as well as most brush-on medical adhesives. They contain a lab tested, non-toxic, citrus-based solution that may also be used to remove these types of medical adhesives or adhesive residue from skin and appliances in preparation for the use of a new adhesive strip/wafer. It is recommended that a male external catheter be changed once a day to promote healthy skin. With the use of Urocare® adhesive remover pads, a male external catheter can be changed quickly and easily. Key Features: • NON-TOXIC—Lab Tested, non-toxic and free from harsh solvents. • Citrus-Based—Fresh citrus scent and biodegradable. • Many Uses—Use on nitro patches, tens units, electrodes, even tar. • 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 • Alcohol-Free Formula • 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?
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
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
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
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FDA Product Code

[?]
Product Code Product Code Name
KOX Solvent, Adhesive Tape
EZR Cement, Stomal Appliance, Ostomy
NNX Device, Incontinence, Urosheath Type, Non-Sterile
KGX Tape And Bandage, Adhesive
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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
Width: 2.25 Inch
Depth: 0.1 Inch
Height: 2.25 Inch
Weight: 0.004 Pound
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Device Record Status

45bbbb89-9244-4af1-8125-1fa0572542a7
November 09, 2022
5
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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