American Red Cross Y7825A1

GUDID B268Y78251

ARC Ready For Baby Kit

TOMY INTERNATIONAL, INC.

Baby care kit

• Primary Device ID: B268Y78251
• NIH Device Record Key: 28f958b8-9653-454e-81bc-b705013d9d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: American Red Cross
• Version Model Number: Y7825
• Catalog Number: Y7825A1
• 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	B268Y78251 [Package]; Package: Retail Package [1 Units]; In Commercial Distribution
HIBCC	B268Y78253 [Package]; Package: Inner Carton [3 Units]; In Commercial Distribution
HIBCC	B268Y78259 [Package]; Contains: B268Y78253; Package: Master Carton [4 Units]; In Commercial Distribution

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [American Red Cross]

• B268Y77904: American Red Cross Infrared non-Contact Forehead Thermometer
• B268Y714993: Rectal Thermometer
• B268Y707894: American Red Cross Multi-Use Digital Thermometer
• B268Y70549: American Red Cross Baby Healthcare Kit
• B268Y7054Y70579: Y7057 American Red Cross Healthcare & Grooming Kit (with Thermometer)
• B268Y108964: Ear Thermometer
• B268Y78251: ARC Ready For Baby Kit
• B268Y79161: Thermometer