FDA.report

Actuvi

Primary DI
00199284197749
Brand
Actuvi
Company
Actuvi LLC
Model
1.0
Device description
Actuvi is a platform that allows clinics to provide digital care to monitor and improve patient health. It integrates patient data sets, patient-reported experiences, along with data from physiological devices and third-party apps, all charted and to be monitored in one place, breaking down traditional data silos.
Published
2025-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OUGMedical Device Data System

Product Code Classifications

CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00199284197749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00199284197749001992841977491992841977490199284197749

GMDN Terms

TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

Sterilization Methods

Method

Contacts

PhoneEmail
4697776133info@actuvi.com

Regulatory Flags

DUNS number
119242208
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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