EchoGo

Primary DI
05060634690041
Brand
EchoGo
Company
ULTROMICS LIMITED
Model
Heart Failure 1.0
Published
2023-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QUOAdjunctive Heart Failure Status Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUOAdjunctive Heart Failure Status IndicatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222463000EchoGo Heart FailureUltromics Limited2022-11-23QUO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060634690041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060634690041050606346900415060634690041

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
222850684
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060634690072EchoGoWorkstream 1.02026-01-14
05060634690058EchoGoHeart Failure 2.02024-12-17
05060634690065EchoGoAmyloidosis 1.02024-12-17
05060634690027EchoGoCore 2.02022-01-19
05060634690003EchoGo Core2020-10-16
05060634690010EchoGoPro2021-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044849079Vivio SystemVentric HealthQUO2025-09-08
00850044849086Vivio System EKG PatchVentric HealthQUO2025-09-08
00850044849093Vivio System Arm CuffVentric HealthQUO2025-09-08
05060634690058EchoGoULTROMICS LIMITEDQUO2024-12-17
00850044849017Vivio System EKG PatchVentric HealthQUO2023-11-22
00850044849024Vivio System AppVentric HealthQUO2023-11-22
00850044849048Vivio System Arm CuffVentric HealthQUO2023-11-22
00850044849055Vivio SystemVentric HealthQUO2023-11-22