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

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
10768702912836PackageGS148In Commercial Distribution
00768702912839PrimaryGS10
07322541245898Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076870291283610768702912836
00768702912839007687029128397687029128390768702912839
07322541245898073225412458987322541245898

GMDN Terms#

Term, Definition table
TermDefinition
Urine flowmeter, reusableA 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.

Sterilization Methods#

Method table
Method

Contacts#

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

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#

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
00768702600132TENAIDENTIFI SENSORWEAR M/R2016-09-16
00768702600149TENAIDENTIFI SENSORWEAR L/XL2016-09-16
10768702600139TENAIDENTIFI SENSORWEAR M/R2016-09-16
10768702600146TENAIDENTIFI SENSORWEAR L/XL2016-09-16
00768702600200TENAIDENTIFI LOGGER KIT2016-09-16

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