GelMat Consumable NL-SK-6

GUDID 10852788008122

Gel Mat

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 ID: 10852788008122
• NIH Device Record Key: b8a4882c-214f-451a-9095-ef36842f10cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GelMat Consumable
• Version Model Number: NL-SK-2-212
• Catalog Number: NL-SK-6
• Company DUNS: 074301687
• Company Name: NEOLIGHT LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10852788008122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170585

FDA Product Code

• LBI: Unit, Neonatal Phototherapy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-06
• Device Publish Date: 2018-11-09

Devices Manufactured by NEOLIGHT LLC

• 10852788008047 - CloudCover Plus: 2024-02-16 CloudCover Plus (disposable)
• 10852788008177 - CloudCover: 2024-02-16 CloudCover for use with Skylife Phototherapy System
• 10852788008009 - Skylife Lightbed: 2020-01-06 Phototherapy Device
• 10852788008016 - Skylife Controller: 2020-01-06 Device Controller (with system)
• 10852788008023 - GelMat: 2020-01-06 GelMat
• 30852788008058 - Light Module: 2020-01-06 Light Modules (2) installed in system
• 10852788008078 - Skylife System: 2020-01-06 Phototherapy System
• 10852788008092 - Cloud Swaddle: 2020-01-06 Cloud Swaddles (disposable 5 pcs with system - labeled bag)