Duns Number:796452311
Device Description: BED CVR-6X35X83 DYNAMIC AIR-117-PC
Catalog Number
24612
Brand Name
BED CVR-6X35X83 DYNAMIC AIR-117-PC
Version/Model Number
BMC-63583-DA117-PC
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
FMW
Product Code Name
Cover, Mattress (Medical Purposes)
Public Device Record Key
e0a7c5d1-7b5a-4c2c-8362-9870577139fc
Public Version Date
April 07, 2020
Public Version Number
1
DI Record Publish Date
March 30, 2020
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 | 478 |
2 | A medical device with a moderate to high risk that requires special controls. | 8062 |