Duns Number:054164587
Device Description: BED, BARIATRIC ACUTE CARE 5 FUNCTION, 1000 LB CAPACITY,54" DECK WIDTH, INCLUDES POWERF BED, BARIATRIC ACUTE CARE 5 FUNCTION, 1000 LB CAPACITY,54" DECK WIDTH, INCLUDES POWERFIFTH WHEEL, CONTROLS INTERGRATEDINTO HEADBOARD, AND PULLOUTEDGE GUARDS
Catalog Number
-
Brand Name
NA
Version/Model Number
5154PDX-H-G
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 15, 2020
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)
-
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
38c72e0a-da25-434e-960d-5b152c6cd34e
Public Version Date
November 16, 2021
Public Version Number
3
DI Record Publish Date
April 28, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 262 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |