DEVICE: Urocare® Male Urinal Sheath, Large 7" (00792293044105)
Device Identifier (DI) Information
Urocare® Male Urinal Sheath, Large 7"
4410
In Commercial Distribution
4410
UROCARE PRODUCTS, INC.
4410
In Commercial Distribution
4410
UROCARE PRODUCTS, INC.
URINAL, SHEATH, MALE, URINE COLLECTION, LATEX, REUSABLE, LARGE 7" (18CM), 9 OZ (270 ML)
Replacement sheath for Urocare Male Urinal systems and kits #94404, #94403 & #4401 & 4400.
Includes:
1 Standard Bottom Drain Valve #6004 and
Illustrated Use and Care Instructions.
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? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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NNX | Device, Incontinence, Urosheath Type, Non-Sterile |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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: 0.08 Pound |
Total Volume: 270 Milliliter |
Total Volume: 9 Fluid Ounce |
Length: 7 Inch |
Device Size Text, specify: 20mm to 40mm I.D. (Inner Sheath) |
Outer Diameter: 3.38 Inch |
Device Record Status
cef92de8-5ae7-4d16-b025-85028fcfece3
June 01, 2018
2
April 12, 2018
June 01, 2018
2
April 12, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined