Duns Number:177939027
Device Description: Stanley 30 Day IT Bed Sensormat 5 1/2' Cord
Catalog Number
-
Brand Name
Stanley
Version/Model Number
74000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2019
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
-
Product Code
KMI
Product Code Name
Monitor, Bed Patient
Public Device Record Key
76cf2bfa-c631-4bee-a69c-703f4792a661
Public Version Date
March 19, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
30817357021319
Quantity per Package
10
Contains DI Package
10817357021315
Package Discontinue Date
March 19, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 178 |