Urocare® Male Urinal Suspensory Garment, Laced Closure, Large 38" to 46" Waist

Primary DI
00792293044211
Brand
Urocare® Male Urinal Suspensory Garment, Laced Closure, Large 38" to 46" Waist
Company
UROCARE PRODUCTS, INC.
Model
4421
Catalog number
4421
Device description
URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, LARGE 38" TO 46" (97CM TO 117CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94401 & #4401.
Published
2018-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00792293044211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293044211007922930442117922930442110792293044211

GMDN Terms

TermDefinition
Penis/scrotum wearable urinalA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Weight0.18Pound

Sterilization Methods

Method

Regulatory Flags

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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