Catalog Number

NL-SK-8S

Brand Name

CloudCover Plus

Version/Model Number

NL-SK-8S

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)

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

30552a40-fd6f-48a6-8e09-e2facb249c85

Public Version Date

November 19, 2020

Public Version Number

1

DI Record Publish Date

November 11, 2020

Package DI Number

20852788008105

Quantity per Package

5

Contains DI Package

10852788008047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag