FDA.report

Viva Diagnostic

Primary DI
00840309415903
Brand
Viva Diagnostic
Company
Tiger Supplies Inc
Model
ADIME913-M
Device description
"Viva Diagnostics Omni Vital Sign Patient Monitor"
Published
2024-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications

CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840309415903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840309415903008403094159038403094159030840309415903

GMDN Terms

TermDefinition
Multiple physiological parameter spot-check system, clinicalAn electrically-powered device assembly designed for professional use in a clinical setting to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2), blood glucose]; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe, spirometer), and potentially in vitro diagnostic [IVD] analysers (e.g., clinical chemistry analyser, urine analyser).

Sterilization Methods

Method

Regulatory Flags

DUNS number
013719334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00840309415880Viva DiagnosticADIME913-T2024-06-01
00840309416054Viva DiagnosticADIME913-S2024-06-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00884838113770MR Patient Care Adult SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
00884838100978MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
B693SICKBAY034600Sickbay Clinical PlatformMEDICAL INFORMATICS CORP.MWI2026-03-04
03615041990363Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990394Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990431Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990455Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990479Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990486Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990509Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990516Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990547Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990554Capsule SurveillancePhilips North America LLCMWI2026-01-08
00199874784175MedibluMEDIBLU MEDICAL LLCMWI2025-12-23
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.MWI2025-12-10
00732094358933Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
00732094358957Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
00732094358971Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
00732094358988Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
03615040002456Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002470Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002487Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002494Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002500Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002517Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002524Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002531Capsule Vitals PLusPhilips North America LLCMWI2025-07-31
03615040002562Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
B693SICKBAY034500Sickbay Clinical PlatformMedical Informatics Corp.MWI2025-07-28
07045432118377NeoBeat Charging StandLaerdal Medical ASMWI2025-07-25