DEVICE: GTIN, FDA, SonoSite SII (00841517106621)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
GTIN, FDA, SonoSite SII
P24550-40
In Commercial Distribution
P24550
FUJIFILM SONOSITE, INC.
00841517106621
GS1

1
014438860 *Terms of Use
No description.
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
40761 General-purpose ultrasound imaging system
A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ITX Transducer, Ultrasonic, Diagnostic
IYO System, Imaging, Pulsed Echo, Ultrasonic
IYN System, Imaging, Pulsed Doppler, Ultrasonic
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K160734 000
K162045 000
K183235 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
0aa27f0a-3b83-44db-84f8-6e1cfede4eb9
May 26, 2021
1
May 18, 2021
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE