L38v/10-5 MHz

Basic Information

• Brand Name: L38v/10-5 MHz
• Primary DI: 00841517101879
• Version / Model: P19360-18
• Catalog Number: P19360
• Company Name: FUJIFILM SONOSITE, INC.
• Labeler DUNS: 014438860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-20
• Public Version: 3
• Public Version Date: 2018-05-23
• Public Version Status: Update
• Public Device Record Key: c31a0aac-ef8a-4445-8129-fdfa1c366d1a

Device Description

Diagnostic Ultrasound Transducer

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
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40767	Extracorporeal ultrasound imaging transducer, mounted	An ultrasound imaging transducer assembly that is either located within the housing of an ultrasound based scanner system, e.g., a breast scanning system, Doppler flow system, ultrasound based bone absorptiometry or densitometry system; or is mounted on a floor, wall or ceiling suspension allowing the operator to position the transducer assembly outside of the patient's body. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses and detects the ultrasound beam and resulting echoes either mechanically or electronically. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841517101879	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: not applicable
• Type: Handling Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -35 – 65 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -35 – 65 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity