BOEHRINGER® CareDry™ Porifem

Basic Information

• Brand Name: BOEHRINGER® CareDry™ Porifem
• Primary DI: 10816286021045
• Version / Model: 7645
• Company Name: BOEHRINGER LABORATORIES, LLC
• Labeler DUNS: 079991657
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-01
• Public Version: 7
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: 5e40ff68-b8a6-4f5e-b98f-9ba54a8ff7d3
• Distribution End Date: 2022-03-31

Device Description

CareDry™ Sponge

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61157	Female wearable urinal, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00816286021048	GS1	Box	30	Not in Commercial Distribution	2021-04-30
Primary	10816286021045	GS1
Package	60816286021040	GS1	Carton	480	Not in Commercial Distribution	2022-03-31
Package	30816286021049	GS1	Box	30	Not in Commercial Distribution	2022-03-31

Customer Contacts

• Phone: [phone]
• Email: [email protected]