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.
00792293044105
GS1

1
070637129 *Terms of Use
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.
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Device Characteristics

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

GMDN

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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?
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

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Product Code Product Code Name
NNX Device, Incontinence, Urosheath Type, Non-Sterile
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FDA Premarket Submission

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

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
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
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Device Record Status

cef92de8-5ae7-4d16-b025-85028fcfece3
June 01, 2018
2
April 12, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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