Duns Number:796452311
Device Description: BED MAT-3X28X42 CRIB CFT FOAM-CAL 117-PC
Catalog Number
26027
Brand Name
BED MAT-3X28X42 CRIB CFT FOAM-CAL 117-PC
Version/Model Number
BM-32842-CRCF117-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
IKY
Product Code Name
Mattress, Flotation Therapy, Non-Powered
Public Device Record Key
7cd3a27d-ce17-4ceb-97ce-75fce20b2156
Public Version Date
March 27, 2020
Public Version Number
1
DI Record Publish Date
March 19, 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 |