Summit Doppler

Primary DI
00888937002409
Brand
Summit Doppler
Company
Coopersurgical, Inc.
Model
L350R-SD4
Device description
LifeDop 350R Tabletop Doppler with 4.0 MHz Vascular 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
MAAMonitor, Fetal Doppler Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAAMonitor, Fetal Doppler UltrasoundObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090499000LIFEDOP MODEL, L350RSummit Doppler Systems, Inc.2009-03-31MAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937002409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937002409008889370024098889370024090888937002409

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

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
00888937010190MediChoiceCoopersurgical, Inc.MAA2016-09-14
00888937010206MediChoiceCoopersurgical, Inc.MAA2016-09-14
00888937010213MediChoiceCoopersurgical, Inc.MAA2016-09-14
00888937010220MediChoiceCoopersurgical, Inc.MAA2016-09-14
00888937010237MediChoiceCoopersurgical, Inc.MAA2016-09-14
00888937010244MediChoiceCoopersurgical, Inc.MAA2016-09-14
00888937002379Summit DopplerCoopersurgical, Inc.MAA2016-07-21
00888937002386Summit DopplerCoopersurgical, Inc.MAA2016-07-21
00888937002393Summit DopplerCoopersurgical, Inc.MAA2016-07-21
00888937002416Summit DopplerCoopersurgical, Inc.MAA2016-07-21
00888937002423Summit DopplerCoopersurgical, Inc.MAA2016-07-21
00888937002430Summit DopplerCoopersurgical, Inc.MAA2016-07-21
00888937002447Summit DopplerCoopersurgical, Inc.MAA2016-07-21