PLAYHOUSE MD

GUDID 00860013187705

Playhouse MD Fever buddy 3-in-1 Infrared Thermometer (Giraffe)

PLAYHOUSE METHOD INC.

Infrared patient thermometer, skin

• Primary Device ID: 00860013187705
• NIH Device Record Key: 7fac8f43-330f-4087-9f96-3150901fcf12
• Commercial Distribution Discontinuation: 2026-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLAYHOUSE MD
• Version Model Number: ET003
• Company DUNS: 138341064
• Company Name: PLAYHOUSE METHOD 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013187705 [Primary]
GS1	10860013187702 [Package]; Package: Cartoons [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191570

FDA Product Code

• FLL: Continuous Measurement Thermometer
• SDV: Clinical Electronic Thermometer

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: 2025-12-09
• Device Publish Date: 2025-12-01