FDA.reportPublic FDA data

Cetro America Toco Transducer for Oxford Sonicaid

Primary DI
00852519007366
Brand
Cetro America Toco Transducer for Oxford Sonicaid
Company
CETRO AMERICA INC
Model
8032026
Device description
Replacement Toco Transducer for Oxford Sonicaid
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050826000FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERSCetro America2006-04-10HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852519007366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852519007366008525190073668525190073660852519007366

GMDN Terms#

Term, Definition table
TermDefinition
TocodynamometerA pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
12032940121admin@cetroamerica.com

Regulatory Flags#

DUNS number
196275197
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852519007250Cetro America Toco Transducer for IM76/AM6680320072020-09-24
00852519007267Cetro America Toco Transducer for IM77/AM6780320082020-09-24
00852519007274Cetro America Toco Transducer for HP 1350+80320092020-09-24
00852519007281Cetro America Toco Transducer for all Coro models80320102020-09-24
00852519007298Cetro America Toco Transducer for FC, FS, Fetacare80320112020-09-24
00852519007304Cetro America Toco Transducer for IM76/AM66, Waterproof80320182020-09-24
00852519007311Cetro America Toco Transducer for IM77/AM67, Waterproof80320192020-09-24
00852519007328Cetro America Toco Transducer for HP 1350+, Waterproof80320202020-09-24
00852519007335Cetro America Toco Transducer for all Coro models, Waterproof80320212020-09-24
00852519007342Cetro America Toco Transducer for FC, FS, Fetacare, Waterproof80320222020-09-24
00852519007359Cetro America Toco Transducer for HP804080320252020-09-24
00852519007373Cetro America Toco Transducer for HP8040, Waterproof80320282020-09-24
00852519007380Cetro America Toco Transducer for Oxford Sonicaid, Waterproof80320292020-09-24
00852519007397Cetro America Toco Transducer for Sonomed80320332020-09-24
00852519007007Cetro America US Transducer for IM76/AM6680310102016-09-24
00852519007014Cetro America Ultrasound Transducer for IM77/AM6780310112016-09-24
00852519007038Cetro America Ultrasound Transducer for HP804080310132016-09-24
00852519007045Cetro America Ultrasound Transducer for Coro 11680310142016-09-24
00852519007052Cetro America Ultrasound Transducer for FC6/8, FS6/8/10, Kranzbüler80310152016-09-24
00852519007069Cetro America Ultrasound Transducer for Fetacare, Kranzbüler80310162016-09-24

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