FDA.reportPublic FDA data

Digital Ultrasonic Diagnostic Imaging System

Primary DI
06944413800830
Brand
Digital Ultrasonic Diagnostic Imaging System
Company
Edan Instruments, Inc.
Model
DUS 60
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944413800830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413800830069444138008306944413800830

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529173163
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944413837164Diagnostic Ultrasound SystemNano L12 EXP2026-03-09
06944413837188Diagnostic Ultrasound SystemNano L122026-03-09
06944413837171Diagnostic Ultrasound SystemNano C52026-03-09
06944413836532Diagnostic Ultrasound SystemNano C5 EXP2026-03-09
06944413849570Holter ECG and ABP SystemHolterABP2026-03-02
06944413858664TOCO-MECG transducerTOCO-EF2026-02-06
06944413858671TOCO-MECG transducerTOCO-EA2026-02-06
06944413814714Trolley(For medical use)MT-5032025-12-09
06944413819726Trolley(For medical use)MT-8032025-12-09
06944413819733Trolley(For medical use)MT-8112025-12-09
06944413807112Remote Event Marker02.01.2100952025-11-29
06944413804197ECG Cable3-lead, 12-pin, Defib-proof, IEC, Snap2025-09-13
06944413815704ECG Cable6-lead, 12-pin, Defib-proof, Adult/pediatric2025-09-13
06944413815711ECG Cable6-lead, Clip, AHA, Adult/pediatric2025-09-13
06944413815728ECG Cable6-lead, Snap, AHA, Adult/pediatric2025-09-13
06944413815735ECG Cable6-lead, Clip, IEC, Adult/pediatric2025-09-13
06944413815742ECG Cable6-lead, Snap, IEC, Adult/pediatric2025-09-13
06944413838963C.O. AccessoriesConnection cable2025-09-14
06944413838406Patient Monitor CX102025-09-05
06944413838413Patient MonitorCX122025-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974405095104CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
06974405095166CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
00841517112561Sonosite PXFUJIFILM SONOSITE, INC.ITX2026-03-12
16975424198729Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.ITX2026-03-11
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
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
04987670106507DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
04987670106514DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
04987670106521DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
10885632426711HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
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10885632426735HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426742HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426759HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426766HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426773HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426780HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426797HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11