Infa-Therm Mattress 1015

GUDID 00850018561587

Infa-Therm Infant Warming Mattress

INTERNATIONAL BIOMEDICAL, LTD.

Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch Exothermic heat therapy pack/patch

• Primary Device ID: 00850018561587
• NIH Device Record Key: 62a4a2db-394a-4fd1-9a22-d29726295c1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infa-Therm Mattress
• Version Model Number: 1015
• Catalog Number: 1015
• Company DUNS: 073179368
• Company Name: INTERNATIONAL BIOMEDICAL, LTD.
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018561587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221653

FDA Product Code

• IMD: Pack, Hot Or Cold, Disposable

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: 2023-04-17
• Device Publish Date: 2023-04-07

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