Duns Number:073704413
Device Description: MAX FAST - 80" GRID DECK HI/LOW MOB
Catalog Number
QD8250M
Brand Name
MC Healthcare
Version/Model Number
MAX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
dead8293-cb62-4918-87f1-dff1ca486fe3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 11, 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 | 399 |
2 | A medical device with a moderate to high risk that requires special controls. | 711 |