Cloud Swaddle

GUDID 10852788008092

Cloud Swaddles (disposable 5 pcs with system - labeled bag)

NEOLIGHT LLC

Blanket/pad infant phototherapy unit

• Primary Device ID: 10852788008092
• NIH Device Record Key: eb6276ec-4d1f-43a0-a22a-7662475e1745
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cloud Swaddle
• Version Model Number: NL-SK-5
• Company DUNS: 074301687
• Company Name: NEOLIGHT LLC
• Device Count: 5
• 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: true
• 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	10852788008092 [Primary]
GS1	10852788008139 [Unit of Use]

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

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• 00852788008057 - Neolight: 2025-02-03 ICON GO Control Box
• 00852788008064 - Neolight: 2025-02-03 ICON Footswitch
• 00852788008071 - Neolight: 2025-02-03 White Light Module
• 10852788008085 - Neolight: 2025-02-03 ICON Handpiece
• 20852788008020 - Neolight: 2025-02-03 ICON Cart & FA