HILOTHERM Homecare 00100010

GUDID 04250387101647

HILOTHERM Homecare - Cooling device

Hilotherm GmbH

Circulating-fluid localized thermal therapy system control unit

• Primary Device ID: 04250387101647
• NIH Device Record Key: 8ccf4136-cce5-4796-9d82-2020e5ab3a3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HILOTHERM Homecare
• Version Model Number: HTP1 Pro
• Catalog Number: 00100010
• Company DUNS: 332153704
• Company Name: Hilotherm GmbH
• 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: true
• 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
GS1	04250387101647 [Primary]

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

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: 2024-05-29
• Device Publish Date: 2024-05-21

Devices Manufactured by Hilotherm GmbH

• 04250387100541 - Lower face cuff with link: 2024-05-29 Lower face cuff with link
• 04250387100619 - Lower face cuff without link: 2024-05-29 Hilotehrm - Lower face cuff without link
• 04250387101647 - HILOTHERM Homecare: 2024-05-29HILOTHERM Homecare - Cooling device
• 04250387101647 - HILOTHERM Homecare: 2024-05-29 HILOTHERM Homecare - Cooling device