Home GUDID 10768702912836
TENA
Primary DI 10768702912836
Brand TENA
Company Essity Hygiene and Health AB
Model SmartCare Sensor Strip long
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.
Published 2020-09-01
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx false
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name KPN ALARM, CONDITIONED RESPONSE ENURESIS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KPN Alarm, Conditioned Response Enuresis Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10768702912836 Package GS1 48 In Commercial Distribution 00768702912839 Primary GS1 0 07322541245898 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10768702912836 10768702912836 00768702912839 00768702912839 768702912839 0768702912839 07322541245898 07322541245898 7322541245898
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 353945611 Device count 2 DM exempt true Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10193489082739 FITRIGHT MEDLINE INDUSTRIES, INC. KPN 2026-03-05 00193489036414 FITRIGHT MEDLINE INDUSTRIES, INC. KPN 2026-03-05 10193489036411 FITRIGHT MEDLINE INDUSTRIES, INC. KPN 2026-03-05 20193489082736 FITRIGHT MEDLINE INDUSTRIES, INC. KPN 2026-03-05 00619013000015 DRI Sleeper excel ANZACARE LIMITED KPN 2026-02-16 00619013000039 DRI Sleeper eclipse ANZACARE LIMITED KPN 2026-02-16 00619013000183 DRI Sleeper eclipse plus ANZACARE LIMITED KPN 2026-02-16 00854950002689 Chummie Theos Medical Systems, Inc. KPN 2026-01-01 00854950002696 Chummie Theos Medical Systems, Inc. KPN 2026-01-01 00854950002702 Chummie Theos Medical Systems, Inc. KPN 2026-01-01 00854950002719 Chummie Theos Medical Systems, Inc. KPN 2026-01-01 00856455007428 Wicked Smart Wicked Sheets, LLC KPN 2025-11-19 00854950002023 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002030 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002047 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002078 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002085 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002153 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002177 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002184 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002191 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002207 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002269 Guardian Theos Medical Systems, Inc. KPN 2024-01-04 00854950002283 Shield Theos Medical Systems, Inc. KPN 2024-01-04 00854950002290 Shield Theos Medical Systems, Inc. KPN 2024-01-04 00854950002320 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002559 NewU Theos Medical Systems, Inc. KPN 2024-01-04 00854950002566 Smart Theos Medical Systems, Inc. KPN 2024-01-04 00854950002573 Zest Theos Medical Systems, Inc. KPN 2024-01-04 00854950002580 Smart Theos Medical Systems, Inc. KPN 2024-01-04