FDA.report

CorVista® System with CAD Add-On

Primary DI
00869059000436
Brand
CorVista® System with CAD Add-On
Company
Analytics For Life Inc
Model
CorVista System with CAD Add-On
Device description
CorVista System with CAD Add-On
Published
2024-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DQKComputer, diagnostic, programmable

Product Code Classifications

CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions

SubmissionSupplement
K232686000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232686000CorVista® SystemCorvista Health, Inc.2023-09-08QXX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00869059000436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00869059000436008690590004368690590004360869059000436

GMDN Terms

TermDefinition
Multiparameter physiologic analysis workstationA computerized unit intended to be used with a variety of noninvasive sensors (not included) for the non-continuous measurement of a variety of cardiovascular and pulmonary parameters [e.g., blood pressure, electrocardiography (ECG), SpO2, lung volume, airway resistance]; it might also be intended for additional physiologic analysis [e.g., electromyography (EMG), galvanic skin response (GSR)]. It includes sensor inputs, controls (e.g., touchscreen) and is intended to allow viewing, sharing and storage of the data; it is neither intended for continuous monitoring nor stress exercise monitoring.

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius45 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)728-5012support@analytics4life.com

Regulatory Flags

DUNS number
208050922
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00869059000443CorVista® System with PH Add-OnCorVista System with PH Add-On2024-04-19
00869059000429CorVista® System10-00202024-02-06

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