AccessGUDID - DEVICE: EchoInsight (B557ECHOINSIGHT0)

GUDID

Device Identifier (DI) Information

Brand Name: EchoInsight
Version or Model: 3.2.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EPSILON IMAGING

Primary DI Number: B557ECHOINSIGHT0
Issuing Agency: HIBCC
Commercial Distribution End Date: March 11, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 833183200 *Terms of Use

Device Description: Software for analysis of echocardiogram

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):	No
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?
44783	Cardiac mapping system application software	An individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. It is a basic set of application programs and routines used for cardiac mapping computer-controlled imaging which can be upgraded to correct programming errors or to add new system capabilities. An application program package is typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80e39699-e670-4bd1-b808-eb938bea111d
Public Version Date: March 11, 2020
Public Version Number: 2
DI Record Publish Date: March 12, 2019

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

Secondary DI

[?]

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

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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