Duns Number:353945611
Device Description: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TEN 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.
Catalog Number
-
Brand Name
TENA
Version/Model Number
SmartCare Sensor Strip 3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KPN
Product Code Name
ALARM, CONDITIONED RESPONSE ENURESIS
Public Device Record Key
c16abf82-45b5-4408-8a00-12b57caef429
Public Version Date
September 06, 2021
Public Version Number
1
DI Record Publish Date
August 27, 2021
Package DI Number
10768702912898
Quantity per Package
48
Contains DI Package
00768702912891
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |