Duns Number:008503294
Device Description: TOTALCARE SEIZURE PAD RIGHT LOWER
Catalog Number
5764RL
Brand Name
POSEY
Version/Model Number
5746RL
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
-
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
FNL
Product Code Name
Bed, Ac-Powered Adjustable Hospital
Public Device Record Key
a75eeb70-c1d1-46c9-a236-98cd28e8dbd8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 13, 2016
Package DI Number
20190676000740
Quantity per Package
1
Contains DI Package
10190676000743
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 177 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |