Duns Number:020198912
Device Description: Posey Chair Alarm Pad, 30 Days, 8' Long Cord
Catalog Number
8309EL
Brand Name
N/A
Version/Model Number
8309EL
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
460ef7fa-505c-415f-8c27-76fc822f7659
Public Version Date
April 28, 2022
Public Version Number
3
DI Record Publish Date
July 18, 2019
Package DI Number
57613327500191
Quantity per Package
10
Contains DI Package
07613327500196
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 |