FDA.reportPublic FDA data

Summit Doppler

Primary DI
00888937002386
Brand
Summit Doppler
Company
Coopersurgical, Inc.
Model
L350R-SD2
Device description
LifeDop 350R Tabletop Doppler with 2.0 MHz Fetal 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
00888937002386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937002386008889370023868889370023860888937002386

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler systemA portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.

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
00888937002393Summit DopplerCoopersurgical, Inc.MAA2016-07-21
00888937002409Summit 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