Skylife Controller

GUDID 10852788008016

Device Controller (with system)

NEOLIGHT LLC

Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit
Primary Device ID10852788008016
NIH Device Record Keyb6ca30cc-1328-4015-bd1c-84df68ff4e7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkylife Controller
Version Model NumberNL-SK-1
Company DUNS074301687
Company NameNEOLIGHT LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com
Phone949-233-5831
Emailalan@theneolight.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110852788008016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBIUnit, Neonatal Phototherapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-06
Device Publish Date2018-11-09

Devices Manufactured by NEOLIGHT LLC

10852788008047 - CloudCover Plus2024-02-16 CloudCover Plus (disposable)
10852788008177 - CloudCover2024-02-16 CloudCover for use with Skylife Phototherapy System
10852788008009 - Skylife Lightbed2020-01-06 Phototherapy Device
10852788008016 - Skylife Controller2020-01-06Device Controller (with system)
10852788008016 - Skylife Controller2020-01-06 Device Controller (with system)
10852788008023 - GelMat2020-01-06 GelMat
30852788008058 - Light Module2020-01-06 Light Modules (2) installed in system
10852788008078 - Skylife System2020-01-06 Phototherapy System
10852788008092 - Cloud Swaddle2020-01-06 Cloud Swaddles (disposable 5 pcs with system - labeled bag)
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