Duns Number:796452311
Device Description: BED COVER-6X36X84-FITS BM2 FLAT DECK SLOPED HEEL FOAM MAT-POLYCARB
Catalog Number
27256
Brand Name
BED COVER-6X36X84-FOR BM2 MAT-POLYCARB
Version/Model Number
BMC-63684-BM2-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
a73b3f98-7701-4d58-9252-b904ec246bb5
Public Version Date
December 28, 2021
Public Version Number
1
DI Record Publish Date
December 20, 2021
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 |