AccessGUDID - DEVICE: L25E/13-6 MHz (00841517103989)

GUDID

Device Identifier (DI) Information

Brand Name: L25E/13-6 MHz
Version or Model: P07634-71A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P07634
Company Name: FUJIFILM SONOSITE, INC.

Primary DI Number: 00841517103989
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014438860 *Terms of Use

Device Description: Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultrasound transducer.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40768	Extracorporeal ultrasound imaging transducer, hand-held	A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, ultrasonic, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053069	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -35 and 65 Degrees Celsius
Special Storage Condition, Specify: N/A
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -35 and 65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 99348443-7ee5-41e1-95b2-f37c3e8c3210
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 11, 2019