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.
00792293060228
GS1

1
070637129 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
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?
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.
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
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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
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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
Outer Diameter: 0.84 Inch
Height: 1.24 Inch
Weight: 0.013 Pound
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Device Record Status

031ae4f0-151a-46f4-afa5-e672ce03f162
July 06, 2018
2
May 29, 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
10792293060225 12 00792293060228 In Commercial Distribution Case
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Secondary DI

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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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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