FDA.reportPublic FDA data

Terason

Primary DI
00852698007089
Brand
Terason
Company
TERATECH CORPORATION
Model
PDOF
Device description
The Terason PDOF is a general-purpose Doppler transducer. The intended uses include: adult and pediatric cardiac ultrasound Doppler imaging.
Published
2018-04-06
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852698007089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852698007089008526980070898526980070890852698007089

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler system probeA hand-operated component of a foetal Doppler system which is placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8668372766techsupport@terason.com

Regulatory Flags#

DUNS number
836416321
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852698007218TerasonuSmart3200T2021-03-24
00852698007508TerasonuSmart3200T Plus2021-03-24
00852698007300TerasonuSmart3200T2020-10-13
00852698007386TerasonuSmart3200T2020-10-13
00852698007409Terason8BP42020-10-13
00852698007416TerasonuSmart3200T2020-10-13
00852698007003Terason5C2A2018-04-06
00852698007010Terason15L42018-04-06
00852698007027Terason4V2A2018-04-06
00852698007034Terason8EC4A2018-04-06
00852698007041Terason8L22018-04-06
00852698007058Terason8V3A2018-04-06
00852698007065Terason9MC32018-04-06
00852698007072Terason16HL72018-04-06
00852698007096Terason12L5A2018-04-06
00852698007102TerasonuSmart33002018-04-06
00852698007119TerasonuSmart3200T2018-04-06
00852698007126TerasonuSmart3300 Cart2018-04-06
00852698007133TerasonuSmart3300 MUX2018-04-06
00852698007140Terason15L4A2018-04-06

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
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
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
04987670106088CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-07-24
00841436122061Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125833Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125857Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126045Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126656Multi-Purpose Workstation ™ StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126663CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16