Device
Non-invasive, single-use device for management of urinary incontinence in adults with male anatomy
Manufacturer
Wellspect AB
Wellspect AB
Model: 38021
Catalog: 3802140
DI: 07333387056623
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-04-27
Current Version: 2026-05-05
Description
Non-invasive, single-use device for management of urinary incontinence in adults with male anatomy
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
524d60af-1cac-4c20-a859-e57d1ecb61cf
Distribution Status:
In Commercial Distribution
DUNS Number:
351118942
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
07333387055336
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
3
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
07333387056623
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07333387056623
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
07333387056845
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
24
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
07333387055336
Item #3 - Device ID Issuing Agency:
GS1
Item #4 - Device ID:
07333387056852
Item #4 - Pkg Status:
In Commercial Distribution
Item #4 - Pkg Quantity:
8
Item #4 - Device ID Type:
Package
Item #4 - Contains DINumber:
07333387055343
Item #4 - Device ID Issuing Agency:
GS1
Item #5 - Device ID:
07333387055343
Item #5 - Pkg Status:
In Commercial Distribution
Item #5 - Pkg Quantity:
30
Item #5 - Device ID Type:
Package
Item #5 - Contains DINumber:
07333387056623
Item #5 - Device ID Issuing Agency:
GS1
GMDN
Code: 34929
Name: Urinary incontinence penis sheath/port, single-use
Definition:
A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
FDA Product Codes
NZU
Collector, urine, powered, non indwelling catheter
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Store the products in room temperature, 60-77°F