Model: PWA300H
Catalog: PWA300H
DI: 00801741234514
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-07
Current Version: 2026-05-15
Description
PureWick Urine Collection System
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
17318c8c-2c58-44be-873f-948c53eeb841
Distribution Status:
In Commercial Distribution
DUNS Number:
016898496
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 - Pkg Type:
Case
Item #1 - Device ID:
10801741234511
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
100
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00801741234514
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00801741234514
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 60917
Name: Bed incontinence system
Definition:
An assembly of devices intended to be fitted to a home bed and used by an incontinent/bed-bound patient for the removal of excrement and subsequent washing during bed occupancy. It includes a mains electricity (AC-powered) air/water pumping unit with heated water reservoir; waste container; and controls connected via relevant tubing to a suction cup, which conforms to the patient’s perineum. It may also include a bed washing/suction hose for general body cleaning, and a shaped mattress to accommodate the system tubing. Waste (i.e., faeces, urine, and waste water) is intended to be removed through suction; a supply of water and air is used to clean and dry the patient after waste removal.
FDA Product Codes
NZU
Collector, urine, powered, non indwelling catheter