FDA.reportPublic FDA data

Cetro America Toco Transducer for IM77/AM67

Primary DI
00852519007267
Brand
Cetro America Toco Transducer for IM77/AM67
Company
CETRO AMERICA INC
Model
8032008
Device description
Replacement Toco Transducer for Advanced Medical Systems/Spacelabs Medical model IM77/AM67 fetal monitors.
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
00852519007267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852519007267008525190072678525190072670852519007267

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
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
00852519007366Cetro America Toco Transducer for Oxford Sonicaid80320262020-09-24
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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