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

-