BOON

GUDID B268B111859

BOON Care Health Kit (Thermometer)

TOMY INTERNATIONAL, INC.

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: 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

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