Transonic

Basic Information

• Brand Name: Transonic
• Primary DI: 08774660000343
• Version / Model: HCS3012-5
• Company Name: TRANSONIC SYSTEMS INC.
• Labeler DUNS: 101317451
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-28
• Public Version: 4
• Public Version Date: 2021-11-05
• Public Version Status: Update
• Public Device Record Key: c5f96bcb-9714-4934-8e76-60a85dd0d67c
• Distribution End Date: 2021-10-01

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	870.1435	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10615	Thermal-dilution cardiac output unit	A unit that measures the blood flow from the heart using the indicator dilution technique, in which a thermal indicator (e.g., cold saline solution or other indicator solution) is injected upstream of the heart and monitored on the downstream side by a balloon-tipped (flow-directed) catheter with a temperature probe. The measured results are reproduced by this device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08774660000343	GS1

Premarket Submissions

Submission Number	Supplement Number
K080116	000