FDA.report

Vave

Primary DI
00850001977036
Brand
Vave
Company
Vave Health, Inc.
Model
VUSP3
Catalog number
VUSP3
Device description
Phased Personal Ultrasound, Battery, and Battery Charger
Published
2021-06-14
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

Contact Domains

Product Codes

CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions

SubmissionSupplement
K191541000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K191541000Vave Personal Ultrasound SystemVave Health, Inc.2019-07-10IYO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850001977036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001977036008500019770368500019770360850001977036

GMDN Terms

TermDefinition
Noninvasive vascular ultrasound system, battery-poweredA hand-held, battery-powered device assembly consisting of a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis, and the vascular states of partially severed extremities), ankle pressure index, and/or blood flow wave form recording.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure620 KiloPascal1060 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure620 KiloPascal1060 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
877-828-3435info@vavehealth.com

Regulatory Flags

DUNS number
084088994
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
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
00850001977104VaveVA-03032024-11-04
00850001977098VaveVA-01332024-09-24
00850001977081VaveVA-03272024-09-23
00850001977005VaveVP3VP32021-06-14
00850001977012VaveVBTVBT2021-06-14
00850001977029VaveVCGVCG2021-06-14
00850001977043VaveVUAVUA2021-06-14
00850001977050VaveVA-0175VA-01752021-06-14

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