TENA

Basic Information

• Brand Name: TENA
• Primary DI: 00768702600149
• Version / Model: IDENTIFI SENSORWEAR L/XL
• Company Name: Essity Hygiene and Health AB
• Labeler DUNS: 353945611
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-06-06
• Public Version Status: Update
• Public Device Record Key: da39e3ac-6e08-4bd5-bf26-c056e77efe8c

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
11239	Adult nappy	A disposable undergarment (a nappy or diaper) composed of absorbent material and worn between the legs used to collect urine and faeces from an incontinent adult patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10768702600146	GS1	Case	2	In Commercial Distribution
Primary	00768702600149	GS1
Unit of Use	07322540881400	GS1

Customer Contacts

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