FDA.reportPublic FDA data

Summit Doppler

Primary DI
00888937010060
Brand
Summit Doppler
Company
Coopersurgical, Inc.
Model
C250CV
Device description
LifeDop 250 Professional Vascular Combination with 5.0 MHz and 8.0 MHz Probes
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
HEPMonitor, Blood-Flow, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEPMonitor, Blood-Flow, UltrasonicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024197000LIFEDOP DOPPLERSummit Doppler Systems, Inc.2003-01-03KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60888937010062PackageGS11In Commercial Distribution
00888937010060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6088893701006260888937010062
00888937010060008889370100608889370100600888937010060

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound systemAn electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.

Regulatory Flags#

DUNS number
801895244
Device count
1
Kit
true
Serial number
true
No natural rubber latex
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B632MDB01009MedibluMEDIBLU MEDICAL LLCHEP2020-06-25
B510PD1000PRO1ADVANCED POCKET DOPPLERADVANCED INSTRUMENTATIONS, INC.HEP2020-04-17
B510PD100PRO1ADVANCED POCKET DOPPLERADVANCED INSTRUMENTATIONS, INC.HEP2020-04-17
GYNXD12500Sonotrax Pro Fetal DopplerGYNEX CORPORATIONHEP2017-01-19
GYNXDB12450Sonotrax Basic Fetal DopplerGYNEX CORPORATIONHEP2017-01-19
40612479199628McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199635McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199642McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199710McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199727McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199734McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
00888937010312MediChoiceCoopersurgical, Inc.HEP2016-09-23
00815871020367E-STAvanteHEP2016-09-23
00815871020374E-STAvanteHEP2016-09-23
00815871020381E-STAvanteHEP2016-09-23
00815871020398E-STAvanteHEP2016-09-23
00815871020404E-STAvanteHEP2016-09-23
00815871020411E-STAvanteHEP2016-09-23
00815871020428E-STAvanteHEP2016-09-23
00815871021494E-ST ProAvanteHEP2016-09-23
00382830028011NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-23
00382830028004NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-21
00382830028172NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-21
00382830028189NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-21
00382830028288NATUS NEUROLOGY NATUS NEUROLOGY INCORPORATEDHEP2016-09-15
00382830028295NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-15
00382830028301NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-15
00888937010299MediChoiceCoopersurgical, Inc.HEP2016-09-14
00888937010305MediChoiceCoopersurgical, Inc.HEP2016-09-14
06944413800120Ultrasonic Pocket DopplerEdan Instruments, Inc.HEP2016-09-01