FDA.report

VinehealthPRO

Primary DI
05070000764122
Brand
VinehealthPRO
Company
VINEHEALTH DIGITAL LIMITED
Model
R1 V3
Published
2023-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NXQReminder, Medication

Product Code Classifications

CodeDeviceSpecialtyClass
NXQReminder, MedicationPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05070000764122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05070000764122050700007641225070000764122

GMDN Terms

TermDefinition
Clinical management support softwareAn application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.

Sterilization Methods

Method

Regulatory Flags

DUNS number
224509890
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05070000764115Vinehealth Cancer CompanionR1 V32023-01-26

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