American Red Cross

GUDID B268Y714993

Rectal Thermometer

TOMY INTERNATIONAL, INC.

General-purpose patient temperature probe, reusable

• Primary Device ID: B268Y714993
• NIH Device Record Key: 513ed649-4f2c-4626-87e3-8650dc286cc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: American Red Cross
• Version Model Number: Y7149
• 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	B268Y71490 [Primary]
HIBCC	B268Y71491 [Package]; Contains: B268Y71490; Package: Retail [1 Units]; In Commercial Distribution
HIBCC	B268Y714960 [Package]; Contains: B268Y71490; Package: Inner [4 Units]; In Commercial Distribution
HIBCC	B268Y714993 [Package]; Contains: B268Y714960; Package: Master [9 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-05-29

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