BiliCocoon™ Service Kit BCC010-SK10

GUDID 03760012570119

NEOMEDLIGHT

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: 03760012570119
• NIH Device Record Key: 6621a17f-eb33-482d-a33c-edc7c4920194
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiliCocoon™ Service Kit
• Version Model Number: BCC010-SK10
• Catalog Number: BCC010-SK10
• Company DUNS: 265910339
• Company Name: NEOMEDLIGHT
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760012570119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163526

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: 4
• Public Version Date: 2024-02-16
• Device Publish Date: 2017-11-03

Devices Manufactured by NEOMEDLIGHT

• 03760012570003 - BiliCocoon™ Light Box: 2024-02-16
• 03760012570010 - BiliCocoon™ Nest System: 2024-02-16
• 03760012570027 - BiliCocoon™ Nest Pad: 2024-02-16
• 03760012570058 - BiliCocoon™ Bag System: 2024-02-16
• 03760012570065 - BiliCocoon™ Bag Pad: 2024-02-16
• 03760012570096 - BiliCocoon™ Fixation System: 2024-02-16
• 03760012570119 - BiliCocoon™ Service Kit: 2024-02-16
• 03760012570119 - BiliCocoon™ Service Kit: 2024-02-16