Duns Number:005249268
Device Description: Head Spring Section for HB6 Bariatric Bed
Catalog Number
3150
Brand Name
PMI Probasics®
Version/Model Number
3150
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 14, 2016
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
39846f57-5c63-4cbf-ab2b-2d7f53c62854
Public Version Date
September 17, 2018
Public Version Number
3
DI Record Publish Date
March 14, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 52 |