physIQ Personalized Physiology Analytics Engine

Primary DI
00860004366263
Brand
physIQ Personalized Physiology Analytics Engine
Company
PHYSIQ, INC
Model
2
Device description
physIQ Personalized Physiology Analytics Engine
Published
2022-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLBMultivariate Vital Signs Index

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLBMultivariate Vital Signs IndexCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142512000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142512000Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)2015-06-11PLB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004366263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004366263008600043662638600043662630860004366263

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 855-869-9054support@physIQ.com

Regulatory Flags#

DUNS number
079107007
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023120267physIQ Patient KitModel AC2022-09-26
00850023120274physIQ Patient KitModel AD2022-09-26
00850023120250physIQ Patient KitModel AB2022-06-28
00850023120243physIQ Patient KitModel AA2022-06-13
00850023120236physIQ Patient KitModel Z2022-05-20
00850023120212physIQ Patient KitModel X2022-04-01
00850023120229physIQ Patient KitModel Y2022-04-01
00850023120205physIQ Patient KitModel W2022-03-04
00850023120182physIQ Patient KitModel U2022-01-21
00850023120199physIQ Patient KitModel V2022-01-21
00860004366256physIQ Heart Rhythm and Respiration Module32022-01-10
00850023120168physIQ Patient KitModel S2021-11-23
00850023120175physIQ Patient KitModel T2021-11-23
00850023120144physIQ Patient KitModel Q2021-11-05
00850023120151physIQ Patient KitModel R2021-11-05
00850023120137physIQ Patient KitModel P2021-08-25
00850023120069physIQ Patient KitModel I2021-07-26
00850023120076physIQ Patient KitModel J2021-07-26
00850023120083physIQ Patient KitModel K2021-07-26
00850023120090physIQ Patient KitModel L2021-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350140270027NAVOYCDSAlgoDx ABPLB2026-05-13
00863061000316T3 PLATFORM SOFTWAREETIOMETRY INC.PLB2026-03-17
00863061000323ETIOMETRY PLATFORMETIOMETRY INC.PLB2026-03-17
00850071330038prolaio Personalized Physiology Analytics Engine Software (PPA)Prolaio, Inc.PLB2025-06-13
08809957910002SpassageQSpass Co.,Ltd.PLB2023-06-27
08885018690021Biovitals Analytics EngineBIOFOURMIS SINGAPORE PTE. LTD.PLB2022-10-28
00863061000309T3 Risk Analytics PlatformETIOMETRY INC.PLB2016-09-09