FDA.report

CarbonMed

Primary DI
06974405095166
Brand
CarbonMed
Company
Carbon (Shenzhen) Medical Device Co., Ltd.
Model
Venus Ultimate-Uro
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions

SubmissionSupplement
K243298000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K243298000Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.2025-04-03IYN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06974405095166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06974405095166069744050951666974405095166

GMDN Terms

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.

Regulatory Flags

DUNS number
702328173
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
06974405095050CarbonMedVN-T01-1.2(18G)×2002026-05-26
06974405095074CarbonMedVE-C012026-05-26
06974405095104CarbonMedVenus Ultimate-Dual2026-05-26
06974405095159CarbonMedVenus Ultimate-Hepa2026-05-26
06974405095173CarbonMedVE-CL01-332026-05-26
06974405095180CarbonMedVE-L012026-05-26
06974405095197CarbonMedVN-T01-1.2(18G)×1002026-05-26
06974405095203CarbonMedVN-T01-1.2(18G)×1502026-05-26
06974405095210CarbonMedCMBNA/18152026-05-26
06974405095227CarbonMedCMBNA/18102026-05-26
06974405097290CarbonMedVE-CL01-342026-05-26
06974405097306CarbonMedVE-CL01-352026-05-26
06974405097313CarbonMedVE-CL01-362026-05-26
06974405097320CarbonMedVE-CL01-372026-05-26
06974405097559CarbonMedVE-C022026-05-26
06974405095067CarbonMedCMBNA/18202026-05-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00845225012939IntraSight PlusPhilips Image Guided Therapy CorporationIYO2026-05-26
00845225012946IntraSight PlusPhilips Image Guided Therapy CorporationIYO2026-05-26
06974405095104CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
06974405095104CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
06974405095104CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYN2026-05-26
06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYN2026-05-26
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM ADVANCED INSTRUMENTATIONS, INC.IYO2026-03-24
00841517112561Sonosite PXFUJIFILM SONOSITE, INC.ITX2026-03-12
16975424198729Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.ITX2026-03-11
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
10841716103992ACIST HDi™ CartACIST MEDICAL SYSTEMS, INC.IYO2026-03-04
04987670102721PHASED ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102745LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102752LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102769PHASED ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102783LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102806CW DOPPLER PENCIL TRANSDUCERCANON INC.ITX2026-03-01
04987670102813DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-03-01
04987670102820CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102837ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102844LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102851ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102868ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102875CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102882CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01