Device
PureWick Flex Female External Catheter Kit w/ Adhesive, Acute Care
Manufacturer
C. R. Bard, Inc.
C. R. Bard, Inc.
Model: PWF030KXS
Catalog: PWF030KXS
DI: 10801741239219
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
PureWick Flex Female External Catheter Kit w/ Adhesive, Acute Care
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
acfe057f-8aa4-4bab-8dc1-a7b9f9433780
Distribution Status:
In Commercial Distribution
DUNS Number:
016898496
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
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:
Yes
Identifiers
Device ID:
10801741239219
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61157
Name: Female wearable urinal, single-use
Definition:
A non-sterile, urine drainage device designed for women that typically consists of a moulded collection cup, which may be partially inserted into the vagina, and a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. 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