EUP-ES52E

Basic Information

• Brand Name: EUP-ES52E
• Primary DI: 04573596211656
• Version / Model: EUP-ES52E
• Company Name: FUJIFILM HEALTHCARE CORPORATION
• Labeler DUNS: 680160734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-18
• Public Version: 2
• Public Version Date: 2022-08-04
• Public Version Status: Update
• Public Device Record Key: 73e374f8-685d-45a9-91df-ab5d7be7fad6

Device Description

Probe

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	892.1550	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37891	Oesophageal ultrasound imaging transducer, reusable	An ultrasound imaging transducer assembly enclosed in a fluid-resistant, acoustically- and electrically-insulated housing, designed to be inserted and positioned in the oesophagus to obtain ultrasound images of the heart and/or to navigate devices requiring ultrasound guidance and placement (e.g., endoscopy equipment or needle biopsy equipment). Also known as an oesophageal endosonography probe or transducer, it is composed of either a single transducer element or an array of transducer elements, i.e., piezoelectric element(s), active element(s), or crystal(s), and associated damping, backing, and matching layer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04573596211656	GS1
Previous	04580292773791	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 68 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 68 – 106 KiloPascal