FDA.reportPublic FDA data

6LB7E Ultrasonic Probe(FDA)

Primary DI
06944904098142
Brand
6LB7E Ultrasonic Probe(FDA)
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
120-005176-00
Published
2019-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
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
06944904098142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904098142069449040981426944904098142

GMDN Terms#

Term, Definition table
TermDefinition
Rectal/vaginal ultrasound imaging transducerAn invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654671304
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
06936415904661MR Na/K Check Solution105-011386-002026-01-23
06936415904678MR Detergent Solution105-011383-002026-01-23
06936415904685MR Buffer Solution105-011382-002026-01-23
06944904084459Chemistry AnalyzerCLC720i2026-01-23
06903053010641M-30CFL LYSEM-30CFL105-026307-002026-01-22
06936415908805M-30CFL LYSEM-30CFL105-006209-002026-01-22
06936415908812M-30CFL LYSEM-30CFL105-006210-002026-01-22
06936415994457PROBE CLEANSERPROBE CLEANSER105-009432-002026-01-22
06944904030210PROBE CLEANSERPROBE CLEANSER105-002225-002026-01-22
06944904093116M-5LEO(I) LyseM-5LEO(I)105-011724-002026-01-22
06944904093123M-5LEO(I) LyseM-5LEO(I)105-011725-002026-01-22
06944904093130M-5LEO(II) LyseM-5LEO(II)105-011729-002026-01-22
06944904093147M-5LEO(II) LyseM-5LEO(II)105-011730-002026-01-22
06944904093154M-53LH LYSEM-53LH105-011734-002026-01-22
06944904093161M-53LH LYSEM-53LH105-011735-002026-01-22
06944904096674SV600 VentilatorSV6002025-01-17
06944904096681SV800 VentilatorSV8002025-01-17
06903053001755Diagnostic Ultrasound SystemTE5 MAX2026-01-10
06903053001762Diagnostic Ultrasound SystemTE7 Max2026-01-10
06903053001779Diagnostic Ultrasound SystemTE92026-01-10

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
10885632426728HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
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