bili-hut™ fully disposable convenience kit (5-Pack)

GUDID 00810101280542

LITTLE SPARROWS TECHNOLOGIES LLC

Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit

• Primary Device ID: 00810101280542
• NIH Device Record Key: ecc86e30-5fd5-413d-a119-9d0daac4ee13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bili-hut™ fully disposable convenience kit (5-Pack)
• Version Model Number: 0133FDK5
• Company DUNS: 078764736
• Company Name: LITTLE SPARROWS TECHNOLOGIES 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810101280542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190899

FDA Product Code

• LBI: Unit, Neonatal Phototherapy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-03
• Device Publish Date: 2024-03-26

Devices Manufactured by LITTLE SPARROWS TECHNOLOGIES LLC

• 00810101280504 - bili-hut™ fully disposable nest & mattress (5-Pack): 2024-04-03
• 00810101280542 - bili-hut™ fully disposable convenience kit (5-Pack): 2024-04-03
• 00810101280542 - bili-hut™ fully disposable convenience kit (5-Pack): 2024-04-03
• 00810101280023 - bili-hut™: 2022-03-18
• 00810101280047 - bili-hut™: 2022-03-18
• 00810101280054 - bili-hut™: 2022-03-18
• 00810101280405 - bili-hut™: 2022-03-18
• 00810101280412 - bili-hut™ fully disposable nest & mattress: 2022-03-18
• 00810101280436 - bili-hut™ disposable nest liner & mattress: 2022-03-18