Duns Number:079220324
Device Description: Hospital Bariatric Bed with Drive
Catalog Number
-
Brand Name
EZ WIDER BARIATRIC BED
Version/Model Number
ASM100130
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OSI
Product Code Name
Bariatric Bed
Public Device Record Key
02fa2076-0ab8-49d4-8c34-b4914e2bb85f
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 21, 2018
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 | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |