BOON

GUDID B268B111859

BOON Care Health Kit (Thermometer)

TOMY INTERNATIONAL, INC.

Baby care kit

• Primary Device ID: B268B111859
• NIH Device Record Key: ac142008-18f6-4c76-bd2e-ddf57bff9969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOON
• Version Model Number: B11185
• Company DUNS: 065183758
• Company Name: TOMY INTERNATIONAL, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B268B111850 [Primary]
HIBCC	B268B111851 [Package]; Contains: B268B111850; Package: Retail pkg [1 Units]
HIBCC	B268B111854 [Package]; Contains: B268B111851; Package: Inner Carton [4 Units]
HIBCC	B268B111859 [Package]; Contains: B268B111854; Package: Master Carton [3 Units]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043110

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2020-01-20
• Device Publish Date: 2017-02-11

Devices Manufactured by TOMY INTERNATIONAL, INC.

• B268Y7078A81 - The First Years: 2025-09-30 Multi-Use Digital Thermometer
• B268Y7078A71 - The First Years: 2024-04-02 Multi-Use Digital Thermometer
• B268Y79571 - The First Years: 2024-01-26 Health and Grooming Kit
• B268Y7057A51 - The First Years: 2024-01-22 Health and Grooming Kit
• B268Y7078A61 - The First Years: 2024-01-19 Digital Thermometer
• B268Y79161 - American Red Cross: 2022-04-08 Thermometer
• B268B111859 - BOON: 2020-01-20BOON Care Health Kit (Thermometer)
• B268B111859 - BOON: 2020-01-20 BOON Care Health Kit (Thermometer)
• B268Y78251 - American Red Cross: 2019-11-12 ARC Ready For Baby Kit