Duns Number:020198912
Device Description: Stanley Chair Sensormat Pad, 14 Days, 8' Long Cord
Catalog Number
73030
Brand Name
N/A
Version/Model Number
73030
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)
Yes
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
388fbcef-864d-43bb-ae0f-976fc288ec65
Public Version Date
April 06, 2020
Public Version Number
2
DI Record Publish Date
September 13, 2019
Package DI Number
57613327503277
Quantity per Package
10
Contains DI Package
07613327503272
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 304 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
| U | Unclassified | 12 |