Duns Number:004253936
Device Description: INSTITUTIONAL MATTRESS, 4 X 36 X 80, DENSIFIED POLYESTER CORE, OCEAN BLUE VINYL COVER, 10 INSTITUTIONAL MATTRESS, 4 X 36 X 80, DENSIFIED POLYESTER CORE, OCEAN BLUE VINYL COVER, 10 OZ. CORE
Catalog Number
-
Brand Name
CMATT
Version/Model Number
H11896
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
cf9c0f4d-6bd3-491c-8534-53041c49a246
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
October 26, 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 | 849 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |