FDA.reportPublic FDA data

MediChoice

Primary DI
00888937010190
Brand
MediChoice
Company
Coopersurgical, Inc.
Model
MC350R-SD2
Device description
MediChoice® Display Tabletop Doppler With Recharger And 2 MHz Obstetrical Probe
Published
2016-09-14
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
00888937010190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937010190008889370101908889370101900888937010190

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00888937002447Summit DopplerCoopersurgical, Inc.MAA2016-07-21