Nuby

GUDID 30048526007197

LUV N' CARE, LTD.

Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit Baby care kit

• Primary Device ID: 30048526007197
• NIH Device Record Key: 396de593-90e0-4c7d-9173-964decb697fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nuby
• Version Model Number: 719
• Company DUNS: 108926288
• Company Name: LUV N' CARE, LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00048526007196 [Primary]
GS1	20048526007190 [Package]; Contains: 00048526007196; Package: [4 Units]; In Commercial Distribution
GS1	30048526007197 [Package]; Contains: 20048526007190; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023711

FDA Product Code

• FLL: Thermometer, Electronic, Clinical
• PWN: Baby Care Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-23