Duns Number:962519208
Device Description: Disposable mattress cover for the neoBLUE Cozy LED Phototherapy System
Catalog Number
030760
Brand Name
neoBLUE
Version/Model Number
Cozy Disposable Mattress Cover
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051869,K051869
Product Code
LBI
Product Code Name
Unit, Neonatal Phototherapy
Public Device Record Key
00b4cb69-a7ad-49c0-9e3b-5db5edb9b13e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 29, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |