Catalog Number

BCC221

Brand Name

BiliCocoon™ Bag Disposable

Version/Model Number

BCC221

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

K163526,K163526

Product Code

LBI

Product Code Name

Unit, Neonatal Phototherapy

Public Device Record Key

e388f353-554f-45e0-9577-87a82b7383dc

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

November 03, 2017

Package DI Number

03760012570072

Quantity per Package

50

Contains DI Package

03760012570089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton