TENA

GUDID 07322541306803

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.

Essity Hygiene and Health AB

Urine flowmeter, reusable

• Primary Device ID: 07322541306803
• NIH Device Record Key: c16abf82-45b5-4408-8a00-12b57caef429
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TENA
• Version Model Number: SmartCare Sensor Strip 3
• Company DUNS: 353945611
• Company Name: Essity Hygiene and Health AB
• Device Count: 2
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)722-6659
• Email: essityorders@essity.com
• Phone: +1(866)722-6659
• Email: essityorders@essity.com
• Phone: +1(866)722-6659
• Email: essityorders@essity.com
• Phone: +1(866)722-6659
• Email: essityorders@essity.com
• Phone: +1(866)722-6659
• Email: essityorders@essity.com
• Phone: +1(866)722-6659
• Email: essityorders@essity.com
• Phone: +1(866)722-6659
• Email: essityorders@essity.com
• Phone: +1(866)722-6659
• Email: essityorders@essity.com
• Phone: +1(866)722-6659
• Email: essityorders@essity.com
• Phone: +1(866)722-6659
• Email: essityorders@essity.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768702912891 [Primary]
GS1	07322541306803 [Unit of Use]
GS1	10768702912898 [Package]; Contains: 00768702912891; Package: Case [48 Units]; In Commercial Distribution

FDA Product Code

• KPN: ALARM, CONDITIONED RESPONSE ENURESIS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-06
• Device Publish Date: 2021-08-27

On-Brand Devices [TENA]

• 00768702600200: IDENTIFI LOGGER KIT
• 10768702600146: IDENTIFI SENSORWEAR L/XL
• 10768702600139: IDENTIFI SENSORWEAR M/R
• 10768702912836: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 00768702912822: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 07322541245874: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 00768702912808: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 07322541306803: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 07322541306797: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 07322541306780: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 00768702912846: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar