IDENTIFY HQ01007

GUDID EHUQHQ0100707

The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.

humediQ global GmbH

Radio-frequency identification patient positioning/tracking system application software

• Primary Device ID: EHUQHQ0100707
• NIH Device Record Key: 05bea44b-7a91-47fa-a6f1-d2497afee1dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDENTIFY
• Version Model Number: 1.7
• Catalog Number: HQ01007
• Company DUNS: 314128217
• Company Name: humediQ global GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: +498964956284
• Email: info@humediq.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EHUQHQ0100707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112692

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-20