Duns Number:757459958
Device Description: SIM assess sensor pad MODERATE kit which contains:- 20 x SIM assess sensor pad MODERATE- 9 SIM assess sensor pad MODERATE kit which contains:- 20 x SIM assess sensor pad MODERATE- 9 x SIM pants REGULAR
Catalog Number
-
Brand Name
SIM assess sensor pad kit - MODERATE
Version/Model Number
6022
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130951
Product Code
KPN
Product Code Name
Alarm, Conditioned Response Enuresis
Public Device Record Key
22d1fc61-03ea-4eeb-86a4-cc5655502cac
Public Version Date
June 21, 2021
Public Version Number
5
DI Record Publish Date
August 16, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |