Duns Number:074301687
Device Description: CloudCover (disposable 5 pcs with system - labeled bag)
Catalog Number
-
Brand Name
Cloud Swaddle
Version/Model Number
NL-SK-5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170585,K170585
Product Code
LBI
Product Code Name
Unit, Neonatal Phototherapy
Public Device Record Key
eb6276ec-4d1f-43a0-a22a-7662475e1745
Public Version Date
February 01, 2021
Public Version Number
6
DI Record Publish Date
November 09, 2018
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. | 6 |