Catalog Number

-

Brand Name

bili-hut™ global

Version/Model Number

0130AG

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 10, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LBI

Product Code Name

Unit, Neonatal Phototherapy

Public Device Record Key

40b8343d-07b3-479c-85be-17e682922e38

Public Version Date

March 11, 2022

Public Version Number

2

DI Record Publish Date

January 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-