Z-DOSE29

Basic Information

• Brand Name: Z-DOSE29
• Primary DI: 00810040260001
• Version / Model: v1.0
• Company Name: AGILITI HEALTH, INC.
• Labeler DUNS: 022869937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-18
• Public Version: 1
• Public Version Date: 2020-06-26
• Public Version Status: New
• Public Device Record Key: 6399d9ec-9192-447e-b40d-03f38d98d6f3

Device Description

XR-29 Solution v1.0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40849	CT system computer	A dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a x-ray computed tomography (CT) system and associated image processing, display and analysis functions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810040260001	GS1

Premarket Submissions

Submission Number	Supplement Number
K170273	000