FDA.reportPublic FDA data

Cetro America Ultrasound Transducer for IM77/AM67

Primary DI
00852519007014
Brand
Cetro America Ultrasound Transducer for IM77/AM67
Company
CETRO AMERICA INC
Model
8031011
Device description
Replacement ultrasound transducer for Advanced Medical Systems/SpaceLabs medical IM77/AM67 fetal monitors.
Published
2016-09-24
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
00852519007014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852519007014008525190070148525190070140852519007014

GMDN Terms#

Term, Definition table
TermDefinition
CardiotocographA mains electricity (AC-powered) patient monitor that displays the relationship between maternal labour and the foetal heart rate by means of combining and coordinating uterine contraction and foetal heart monitoring during the perinatal period. The uterine contractions are usually recorded using a tocodynamometer (a pressure transducer) which is strapped onto the mother's abdomen. Commonly known as a tococardiograph or a cardiotocograph (CTG) machine, the heart rate is typically measured with a dedicated ultrasound transducer.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.HGM2026-03-18
B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.HGM2026-03-18
B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.HGM2026-03-18
05051968048233SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048240SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048257SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048264SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048271SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048288SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048295OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048301OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048318OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048325OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048332OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048349OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048356OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048363OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048370OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048387OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048394OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048400OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048417OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048424OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048431OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
06944413814714Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819726Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819733Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413807112Remote Event MarkerEdan Instruments, Inc.HGM2025-11-29
00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
00198953043271CareIntellect PerinatalGe Medical Systems Information Technologies, Inc.HGM2025-11-21