DEVICE: EPIQ 5 Diagnostic Ultrasound System Circular Edition (00884838114210)

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Device Record History
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Device Identifier (DI) Information
EPIQ 5 Diagnostic Ultrasound System Circular Edition
795120
In Commercial Distribution

Philips Ultrasound LLC
00884838114210
GS1

1
063377717 *Terms of Use
10.0.X Circular Edition
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Device Characteristics
MR Unsafe
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
IYN System, Imaging, Pulsed Doppler, Ultrasonic
IYO System, Imaging, Pulsed Echo, Ultrasonic
ITX Transducer, Ultrasonic, Diagnostic
OBJ Catheter, Ultrasound, Intravascular
QIH Automated Radiological Image Processing Software
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
0c34eb05-9d9e-4125-b08d-e83a35251f4a
June 07, 2024
2
April 10, 2024
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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
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Secondary DI

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

[?]
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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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