FDA.report

Vave

Primary DI
00850001977104
Brand
Vave
Company
Vave Health, Inc.
Model
VA-0303
Device description
Software Application 3X version onwards
Published
2024-11-04
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
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions

SubmissionSupplement
K241051000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241051000Vave Wireless Ultrasound SystemVave Health, Inc.2024-08-30IYN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850001977104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001977104008500019771048500019771040850001977104

GMDN Terms

TermDefinition
Hand-held ultrasound imaging system, body-surfaceA battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.

Sterilization Methods

Method

Regulatory Flags

DUNS number
084088994
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
00850001977098VaveVA-01332024-09-24
00850001977081VaveVA-03272024-09-23
00850001977005VaveVP3VP32021-06-14
00850001977012VaveVBTVBT2021-06-14
00850001977029VaveVCGVCG2021-06-14
00850001977036VaveVUSP3VUSP32021-06-14
00850001977043VaveVUAVUA2021-06-14
00850001977050VaveVA-0175VA-01752021-06-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06944413837164Diagnostic Ultrasound SystemEdan Instruments, Inc.IYN2026-03-09
06944413837188Diagnostic Ultrasound SystemEdan Instruments, Inc.IYN2026-03-09
06944413837171Diagnostic Ultrasound SystemEdan Instruments, Inc.IYN2026-03-09
06944413836532Diagnostic Ultrasound SystemEdan Instruments, Inc.IYN2026-03-09
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08809944934936CA2-13MSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08809944936923CM1-8SAMSUNG MEDISON CO., LTD.IYN2026-01-20
08809944942085CM2-11SAMSUNG MEDISON CO., LTD.IYN2026-01-20
08809944942115LM3-27SAMSUNG MEDISON CO., LTD.IYN2026-01-20
08809944942269EV3-15SAMSUNG MEDISON CO., LTD.IYN2026-01-20
06903053001755Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-01-10
06903053001762Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-01-10
06903053001779Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-01-10
06936415912482Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-01-10
06936415978181Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-01-10
06936415978402Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-01-10
06936415981136Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-01-10