Duns Number:066412472
Device Description: Neonatal Series Crib, 3 Side Drop, Raised Clearance Height, Manual Fowler Deck, Confetti P Neonatal Series Crib, 3 Side Drop, Raised Clearance Height, Manual Fowler Deck, Confetti Powder Coat
Catalog Number
E1965CL-MF-3SD_12
Brand Name
E1965CL-MF-3SD_12
Version/Model Number
E1965CL-MF-3SD_12
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
FMS
Product Code Name
Bed, Pediatric Open Hospital
Public Device Record Key
d4404c8e-e0ce-42de-b17a-adebbe204cd0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 09, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |