TENA

Basic Information

• Brand Name: TENA
• Primary DI: 00768702912877
• Version / Model: SmartCare Sensor Strip 1
• Company Name: Essity Hygiene and Health AB
• Labeler DUNS: 353945611
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-08-27
• Public Version: 1
• Public Version Date: 2021-09-06
• Public Version Status: New
• Public Device Record Key: 39bc284d-44c4-4959-8411-c0498564e928

Device Description

The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA SmartCare Sensor Strip. It is an assortment of wetness indicators to be used as an accessory to an absorbent hygiene product used by dependent individuals suffering from incontinence problems.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPN	ALARM, CONDITIONED RESPONSE ENURESIS	Gastroenterology, Urology	876.2040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36337	Urine flowmeter, reusable	A device that is used to measure the flow and volume of urine from a patient during the course of normal urination in order to identify micturation disturbances. The device is usually used by healthcare professionals who instruct the patient to empty their bladder into the measuring chamber of the device; some types may be designed to be used by laymen. This device may use mechanical, electrical, or a combination for the measuring techniques and provide digital measurements such as total voided volume, volume at maximum flow, maximum flow rate, mean flow rate, flow time, and time of maximum flow. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07322541306780	GS1
Primary	00768702912877	GS1
Package	10768702912874	GS1	Case	48	In Commercial Distribution

Customer Contacts

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