AccessGUDID - DEVICE: EchoSolv AS (09309001128005)

GUDID

Device Identifier (DI) Information

Brand Name: EchoSolv AS
Version or Model: 1.5.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ECHOIQ LIMITED

Primary DI Number: 09309001128005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 743631558 *Terms of Use

Device Description: No description.

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):	Yes
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?
64918	Cardiovascular interpretive screening software	An interpretive software program intended to be used in the assessment of risk/probability for having a cardiovascular condition (e.g., significant coronary stenosis) or event (e.g., heart attack, ischemic stroke, unstable angina, coronary revascularization). It typically combines some of the following data: patient demographics, physical measurements, symptoms, medical history, results of the qualitative/quantitative clinical specimen in vitro diagnostic (IVD) tests. It typically creates a risk score or probability that may be used to guide patient management. It is not intended to produce risk scores for renal disease; this software is not an IVD device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241245	000

Device Exempt from Premarket Submission: No 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: 929081fc-1c7a-4f71-9b20-d7cde59503c5
Public Version Date: November 22, 2024
Public Version Number: 1
DI Record Publish Date: November 14, 2024

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: Yes
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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