THERAPY SYSTEM, ARTEK PRO-02 0P9PTATP02

GUDID 00850033615647

THERAPY SYSTEM, ARTEK PRO-02

THERMOTEK, INC.

Circulating-fluid localized thermal therapy system pack, single-use

• Primary Device ID: 00850033615647
• NIH Device Record Key: c8da7151-5359-4d68-beac-a83506dc770a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERAPY SYSTEM, ARTEK PRO-02
• Version Model Number: 0P9PTATP02
• Catalog Number: 0P9PTATP02
• Company DUNS: 847899911
• Company Name: THERMOTEK, 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: true
• Manufacturing Date: true
• 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	00850033615647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061866

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: 2026-03-03
• Device Publish Date: 2026-02-23

Devices Manufactured by THERMOTEK, INC.

• 00850033615227 - Echo Ultrasound Device (PRC): 2026-03-03 Echo Ultrasound Device, Carton
• 00850033615258 - Echo Ultrasound Device (PRC): 2026-03-03 Echo Ultrasound Device, Single
• 00850033615289 - Echo Ultrasound Device (USA): 2026-03-03 Echo Ultrasound Device (USA), Carton
• 00850033615340 - Echo Ultrasound Device (USA): 2026-03-03 Echo Ultrasound Device (USA), Single
• 00850033615371 - Echo BOX, DRESSING & GEL POD PACK, USND, PRC: 2026-03-03 Echo BOX, DRESSING & GEL POD PACK, USND, PRC Single
• 00850033615388 - Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXES: 2026-03-03 Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXES
• 00850033615425 - Echo Ultra Sound Gel Pods, Carton: 2026-03-03 Echo Ultra Sound Gel Pods, Carton
• 00850033615487 - Echo Ultra Sound Gel Pod, Single: 2026-03-03 Echo Ultra Sound Gel Pod, Single