Duns Number:066412472
Device Description: Child Series Crib, Klimer, 3 Side Drop, Gatch Deck, Confetti Powder Coat
Catalog Number
E1982CG-3SD
Brand Name
E1982CG-3SD
Version/Model Number
E1982CG-3SD
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
f6e74320-be23-420d-88d2-b6c40d1b03f5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 16, 2016
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 |