FDA.reportPublic FDA data

Summit Doppler

Primary DI
00888937001990
Brand
Summit Doppler
Company
Coopersurgical, Inc.
Model
SD5V
Device description
Vista 5.0 MHz Vascular Bidirectional Probe
Published
2016-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAFMonitor, Ultrasonic, Nonfetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAFMonitor, Ultrasonic, NonfetalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063600000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063600000VISTA AVSSummit Doppler Systems, Inc.2006-12-19JAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937001990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937001990008889370019908889370019900888937001990

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860011754565Imex ELITE 2MHZ WATERPROOF PROBE V2IMEX, LLCJAF2026-05-18
00860011754572Imex ELITE 2MHZ OB PROBEIMEX, LLCJAF2026-05-18
00860011754589Imex ELITE 8MHZ VASCULAR PROBEIMEX, LLCJAF2026-05-18
00860011754596Elite 5 MHz Vascular ProbeIMEX, LLCJAF2026-05-18
00860011754503Imex Elite 200 DopplerIMEX, LLCJAF2026-05-13
00860011754527Imex Elite 100 DopplerIMEX, LLCJAF2026-05-13
00860011754534Imex CT+ DopplerIMEX, LLCJAF2026-05-13
00860011754541Imex Elite 200R DopplerIMEX, LLCJAF2026-05-13
00860011754558Imex Elite 100R DopplerIMEX, LLCJAF2026-05-13
08033737710869THD SLIDE ONETHD SPAJAF2025-10-30
18033737710354THD SLIDE ONETHD SPAJAF2025-10-30
08051887047918THD SLIDE ONETHD SPAJAF2025-04-03
18051887047915THD SLIDE ONETHD SPAJAF2025-04-03
B4371194904Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B4371198605Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B4371199606Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B437129500Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
18033737710781THD SLIDE ONETHD SPAJAF2022-09-09
08033737710777THD SLIDE ONETHD SPAJAF2022-09-01
18033737710774THD SLIDE ONETHD SPAJAF2022-09-01
05051968044501DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJAF2022-02-07
00852785008289DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
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00852785008401DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008418DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008463DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008470DigiDopNEWMAN MEDICAL LLCJAF2021-06-25