FDA.reportPublic FDA data

TENA

Primary DI
00768702600149
Brand
TENA
Company
Essity Hygiene and Health AB
Model
IDENTIFI SENSORWEAR L/XL
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPNALARM, CONDITIONED RESPONSE ENURESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPNAlarm, Conditioned Response EnuresisGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768702600146PackageGS12In Commercial Distribution
00768702600149PrimaryGS10
07322540881400Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076870260014610768702600146
00768702600149007687026001497687026001490768702600149
07322540881400073225408814007322540881400

GMDN Terms#

Term, Definition table
TermDefinition
Adult nappyA 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.

Contacts#

Phone, Email table
PhoneEmail
+1(866)722-6659essityorders@essity.com

Regulatory Flags#

DUNS number
353945611
Device count
12
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768702912877TENASmartCare Sensor Strip 12021-08-27
00768702912884TENASmartCare Sensor Strip 22021-08-27
00768702912891TENASmartCare Sensor Strip 32021-08-27
00768702912846TENASmartCare Transmitter2021-08-27
07322541306780TENASmartCare Sensor Strip 12021-08-27
07322541306797TENASmartCare Sensor Strip 22021-08-27
07322541306803TENASmartCare Sensor Strip 32021-08-27
00768702912815TENASmartCare Sensor Strip short2020-09-01
00768702912839TENASmartCare Sensor Strip long2020-09-01
00768702912808TENASmartCare Transmitter2020-09-01
07322541245874TENASmartCare Sensor Strip short2020-09-01
00768702912822TENASmartCare Sensor Strip medium2020-09-01
10768702912836TENASmartCare Sensor Strip long2020-09-01
00768702600132TENAIDENTIFI SENSORWEAR M/R2016-09-16
10768702600139TENAIDENTIFI SENSORWEAR M/R2016-09-16
10768702600146TENAIDENTIFI SENSORWEAR L/XL2016-09-16
00768702600200TENAIDENTIFI LOGGER KIT2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489082739FITRIGHTMEDLINE INDUSTRIES, INC.KPN2026-03-05
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10193489036411FITRIGHTMEDLINE INDUSTRIES, INC.KPN2026-03-05
20193489082736FITRIGHTMEDLINE INDUSTRIES, INC.KPN2026-03-05
00619013000015DRI Sleeper excelANZACARE LIMITEDKPN2026-02-16
00619013000039DRI Sleeper eclipseANZACARE LIMITEDKPN2026-02-16
00619013000183DRI Sleeper eclipse plusANZACARE LIMITEDKPN2026-02-16
00854950002689ChummieTheos Medical Systems, Inc.KPN2026-01-01
00854950002696ChummieTheos Medical Systems, Inc.KPN2026-01-01
00854950002702ChummieTheos Medical Systems, Inc.KPN2026-01-01
00854950002719ChummieTheos Medical Systems, Inc.KPN2026-01-01
00856455007428Wicked SmartWicked Sheets, LLCKPN2025-11-19
00854950002023ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002030ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002047ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002078ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002085ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002153ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002177ChummieTheos Medical Systems, Inc.KPN2024-01-04
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00854950002191ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002207ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002269GuardianTheos Medical Systems, Inc.KPN2024-01-04
00854950002283ShieldTheos Medical Systems, Inc.KPN2024-01-04
00854950002290ShieldTheos Medical Systems, Inc.KPN2024-01-04
00854950002320ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002559NewUTheos Medical Systems, Inc.KPN2024-01-04
00854950002566SmartTheos Medical Systems, Inc.KPN2024-01-04
00854950002573ZestTheos Medical Systems, Inc.KPN2024-01-04
00854950002580SmartTheos Medical Systems, Inc.KPN2024-01-04