DEVICE: Versana (00195278300034)

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Device Record History
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Device Identifier (DI) Information
Versana
Balance R2 VS
In Commercial Distribution

GE Medical Systems (China) Co.,Ltd.
00195278300034
GS1

1
654658731 *Terms of Use
Supra R2 basic console for Balance VS
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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
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FDA Product Code

[?]
Product Code Product Code Name
ITX Transducer, ultrasonic, diagnostic
IYN System, imaging, pulsed doppler, ultrasonic
IYO System, imaging, pulsed echo, ultrasonic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K220446 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment Temperature: between -5 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
c38dd3f6-0f24-46a7-88bb-f35d748e2746
June 23, 2023
1
June 15, 2023
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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