FDA.reportPublic FDA data

Summit Doppler

Primary DI
00888937002355
Brand
Summit Doppler
Company
Coopersurgical, Inc.
Model
L250-STN
Device description
LifeDop 250 Professional with 8.0 MHz Sterilizable 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
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
00888937002355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937002355008889370023558889370023550888937002355

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, battery-poweredA hand-held, battery-powered device assembly consisting of a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis, and the vascular states of partially severed extremities), ankle pressure index, and/or blood flow wave form recording.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
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