FDA.reportPublic FDA data

NA

Primary DI
00840682104227
Brand
NA
Company
WIPRO GE HEALTHCARE PRIVATE LIMITED
Model
TOCO TRANSDUCER WATERTIGHT LOOP
Published
2016-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HELMONITOR, HEART RATE, FETAL, ULTRASONIC
HFMMONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HELMonitor, Heart Rate, Fetal, UltrasonicObstetrics/Gynecology2
HFMMonitor, Uterine Contraction, External (For Use In Clinic)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982651000COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCorometrics Medical Systems, Inc.1998-12-11HEL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682104227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682104227008406821042278406821042270840682104227

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(414)355-5000xx@xx.xx

Regulatory Flags#

DUNS number
650140403
Device count
1
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682142724TRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10 BOXB12015827-0012022-12-06
00840682103831COROMETRICS 170 SERIESMODEL 1722016-06-24
00840682103848COROMETRICS 170 SERIESMODEL 1712016-06-24
00840682103879COROMETRICS 170 SERIESMODEL 1742016-06-24
00840682104111N/ATOCO TRANSDUCER WATERTIGHT BUTTON2016-06-24
00840682104210N/AULTRASOUND TRANSDUCER WATERTIGHT BUTTON2016-06-24
00840682104296N/AULTRASOUND TRANSDUCER WATERTIGHT LOOP2016-06-24
00840682116367COROMETRICS 250CX SERIESMODEL 259CX2016-06-24
00840682117081Mini Telemetry System2051444-0022016-06-24
00840682117111Mini Telemetry System2051444-0032016-06-24
00840682117173Mini Telemetry System2051444-0012016-06-24
00840682142564ULTRASOUND TRANSDUCERNA21083462018-11-01
00840682142571TOCO TRANSDUCERNA21083472018-11-01
00840682143240Coro - Round MECG cable AHAMECG12018-10-29
00840682116992Mini Telemetry System2051444-0042016-06-24
00840682117012Mini Telemetry System2051440-0032016-06-24
00840682117067Mini Telemetry System2051440-0042016-06-24
00840682117128Mini Telemetry System2051440-0022016-06-24
00840682117166Mini Telemetry System2051440-0012016-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
20884838059324Avalon Fetal & Maternal PatchPhilips Medical Systems HsgHFM2020-05-25
00884838068179Avalon CL Fetal & Maternal PodPhilips Medizin Systeme Böblingen GmbHHFM2020-05-22
00840682142564ULTRASOUND TRANSDUCERWIPRO GE HEALTHCARE PRIVATE LIMITEDHEL2018-11-01
00840682142571TOCO TRANSDUCERWIPRO GE HEALTHCARE PRIVATE LIMITEDHFM2018-11-01
00884838034235Avalon CL Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-19
00884838002715Avalon TOCO+ TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-03
00884838021471Avalon TOCO MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-03
M745FM10839AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
M745FM10840AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
M745FM10841AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
00814247020284Koala Toco®CLINICAL INNOVATIONS, LLCHFM2016-09-01
20814247020288Koala Toco®CLINICAL INNOVATIONS, LLCHFM2016-09-01
B249VA000380FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA000381FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA001060FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA001061FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002020FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002030FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002190FEATHERLITE AQUAPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002191FEATHERLITE AQUAPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003100FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003101FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003110FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003111FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003120FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18