FDA.reportPublic FDA data

Summit Doppler

Primary DI
00888937002447
Brand
Summit Doppler
Company
Coopersurgical, Inc.
Model
L350R-SDW
Device description
LifeDop 350R Tabletop Doppler with 2.0 MHz Waterproof 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
00888937002447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937002447008889370024478889370024470888937002447

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
00888937027495Endoscopic Seals26153EAU-102026-10-22
00888937027501Endoscopic Seals27550ZAG-102026-10-22
00888937027556Endoscopic SealsC0100132026-10-22
00888937027563Endoscopic SealsC0100142026-10-22
00888937027327ER-SpecC0203002026-08-05
00888937027945ZyMotMulti 850 microLZMH0850M2026-01-23
05060488047336EZ-GripDenudation and Handling Pipettor7-72-28002025-04-11
05060488047343EZ-GripWith Comfort Rest Denudation and Handling Pipettor7-72-28022025-04-11
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06

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
00888937002409Summit DopplerCoopersurgical, Inc.MAA2016-07-21
00888937002416Summit DopplerCoopersurgical, Inc.MAA2016-07-21
00888937002423Summit DopplerCoopersurgical, Inc.MAA2016-07-21
00888937002430Summit DopplerCoopersurgical, Inc.MAA2016-07-21