Duns Number:004253936
Device Description: PREVENTION REPLACEMENT CRIB MATTRESS W/POLYCARBONATE, 5 X 21.5 X 33 (811), CAL 129 / FED 1 PREVENTION REPLACEMENT CRIB MATTRESS W/POLYCARBONATE, 5 X 21.5 X 33 (811), CAL 129 / FED 1633
Catalog Number
H12507-P
Brand Name
CMATT
Version/Model Number
H12507-P
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
7fab9f8a-b67c-4de4-ae5c-7162cdfb4791
Public Version Date
October 12, 2020
Public Version Number
1
DI Record Publish Date
October 02, 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 |