Lunoa L1CHST01

GUDID 08719689344030

Lunoa Chest Strap

NightBalance Holding B.V.

Sleep apnoea bed pillow

• Primary Device ID: 08719689344030
• NIH Device Record Key: be4c2cc3-4af1-404a-b716-e7ff0277daea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lunoa
• Version Model Number: L1CHST01
• Catalog Number: L1CHST01
• Company DUNS: 489925212
• Company Name: NightBalance Holding B.V.
• 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: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719689344030 [Direct Marking]
GS1	08719689344511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180608

FDA Product Code

• MYB: Pillow, cervical (for mild sleep apnea)

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: 2023-09-18
• Device Publish Date: 2018-08-20

On-Brand Devices [Lunoa]

• 08719689344030: Lunoa Chest Strap
• 08719689344092: Lunoa Sleep Position Trainer, US