Catalog Number

BCC010-SK10

Brand Name

BiliCocoon™ Service Kit

Version/Model Number

BCC010-SK10

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

K163526

Product Code

LBI

Product Code Name

Unit, Neonatal Phototherapy

Public Device Record Key

6621a17f-eb33-482d-a33c-edc7c4920194

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-