FDA.reportPublic FDA data

Vave

Primary DI
00850001977005
Brand
Vave
Company
Vave Health, Inc.
Model
VA-0116, VP3
Device description
Vave Phased Ultrasound Probe
Published
2021-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191541000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001977005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001977005008500019770058500019770050850001977005

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Storage And Handling#

Type, Low, High table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
877-828-3435info@vavehealth.com

Regulatory Flags#

DUNS number
084088994
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001977104VaveVA-03302024-11-04
00850001977098VaveVA-01332024-09-24
00850001977081VaveVA-03272024-09-23
00850001977012VaveVBTVBT2021-06-14
00850001977029VaveVA-0252, VCG2021-06-14
00850001977036VaveVA-0182, VUSP32021-06-14
00850001977043VaveVUAVUA2021-06-14
00850001977050VaveVA-0175VA-01752021-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436127028Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127035Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125311CIV-Clear™ Transducer CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125915Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125939Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125953Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127056Cable SleeveCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127186Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGITX2026-07-24
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYN2026-07-24
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
04987670106088CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-07-24
00841436122061Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125338Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23