DEVICE: Urocare® Male Urinal to Latex Leg Bag Adapter (00792293060228)
Device Identifier (DI) Information
Urocare® Male Urinal to Latex Leg Bag Adapter
6022
In Commercial Distribution
6022
UROCARE PRODUCTS, INC.
6022
In Commercial Distribution
6022
UROCARE PRODUCTS, INC.
ADAPTER, MALE URINAL, LEG BAG, URINE COLLECTION, REUSABLE, REPLACEMENT
Replacement Male Urinal Adapter for all Urocare Male Urinal Systems: #94404, #94403, #94402, #94401, #94400, #94399 and Urinal Kits: #4404, #4403, #4402, #4401, #4400 and #4399.
Includes Gasket-Ring #5999 preassembled.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
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Yes | |
No | |
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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? |
---|---|---|---|---|
58924 | Open-ended wearable urine collection bag, non-sterile |
A non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.
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Obsolete | false |
45376 | Penis/scrotum wearable urinal |
A non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals. It is typically held in place with groin and waist straps and has a connected collection bag that functions as the reservoir for the collection of the urine. This device provides an alternative to inserting a catheter or wearing incontinence pads. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NNX | Device, Incontinence, Urosheath Type, Non-Sterile |
NNW | Bag, Urine Collection, Leg, For External Use, Non-Sterile |
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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Outer Diameter: 0.84 Inch |
Height: 1.24 Inch |
Weight: 0.013 Pound |
Device Record Status
031ae4f0-151a-46f4-afa5-e672ce03f162
July 06, 2018
2
May 29, 2018
July 06, 2018
2
May 29, 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 |
---|---|---|---|---|---|
10792293060225 | 12 | 00792293060228 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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