DEVICE: FUJIFILM (04547410332346)

Device Identifier (DI) Information

FUJIFILM
SU-1 PLATINUM FV651A
In Commercial Distribution

FUJIFILM CORPORATION
04547410332346
GS1

1
713565195 *Terms of Use
The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
FDS Gastroscope and accessories, flexible/rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: There must be no condensation.
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

f1c4b803-1b24-4f4d-b21a-3bd5a172efc3
May 23, 2018
3
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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+018002728465
xxx@xxx.xxx
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