Lamaze

GUDID B268Y5288L9

Teether

TOMY INTERNATIONAL, INC.

Teething device, fluid-filled

• Primary Device ID: B268Y5288L9
• NIH Device Record Key: 9d1a10a5-8ae0-4ae9-8708-ee8dc2cabd4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lamaze
• Version Model Number: Y5228L
• Company DUNS: 065183758
• Company Name: TOMY INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	B268Y5288L0 [Primary]
HIBCC	B268Y5288L1 [Package]; Contains: B268Y5288L0; Package: Retail Package [1 Units]; In Commercial Distribution
HIBCC	B268Y5288L6 [Package]; Contains: B268Y5288L1; Package: Inner Carton [6 Units]; In Commercial Distribution
HIBCC	B268Y5288L9 [Package]; Contains: B268Y5288L6; Package: Master Carton [4 Units]; In Commercial Distribution

FDA Product Code

• KKO: Ring, Teething, Fluid-Filled

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: 2019-10-21
• Device Publish Date: 2019-10-11

On-Brand Devices [Lamaze]

• B268L276198: Water Filled Chill Teethers
• B268Y5288L9: Teether