Duns Number:023904428
Device Description: Bed Alarm Sensor Pad 20” x 30”
Catalog Number
-
Brand Name
McKesson
Version/Model Number
162-1128
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
4238a8a1-24b0-4182-a650-c023ff27cd89
Public Version Date
May 06, 2020
Public Version Number
1
DI Record Publish Date
April 28, 2020
Package DI Number
40612479215144
Quantity per Package
20
Contains DI Package
10612479215136
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |