Duns Number:066412472
Device Description: Child Series Crib, Klimer, 2 Side Drop, Gatch Deck, 1 Plexi Side, 1 Plexi Gate, Confetti P Child Series Crib, Klimer, 2 Side Drop, Gatch Deck, 1 Plexi Side, 1 Plexi Gate, Confetti Powder Coat
Catalog Number
-
Brand Name
E1982CG-CH
Version/Model Number
E1982CG-CH
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
da1e4acf-999c-440a-b755-bfdc46d34d94
Public Version Date
April 02, 2020
Public Version Number
1
DI Record Publish Date
March 25, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |