ULTRASOUND TRANSDUCER

Primary DI
00840682142564
Brand
ULTRASOUND TRANSDUCER
Company
WIPRO GE HEALTHCARE PRIVATE LIMITED
Model
NA
Catalog number
2108346
Published
2018-11-01
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HELMonitor, Heart Rate, Fetal, UltrasonicObstetrics/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
00840682142564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682142564008406821425648406821425640840682142564

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
Storage Environment Temperature70 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
650140403
Device count
1
Serial number
true
Manufacturing date on label
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
00840682104227NATOCO TRANSDUCER WATERTIGHT LOOP2016-06-24
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
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
00840682104111N/AWIPRO GE HEALTHCARE PRIVATE LIMITEDHEL2016-06-24
00840682104210N/AWIPRO GE HEALTHCARE PRIVATE LIMITEDHEL2016-06-24
00840682104227NAWIPRO GE HEALTHCARE PRIVATE LIMITEDHEL2016-06-24
00840682104296N/AWIPRO GE HEALTHCARE PRIVATE LIMITEDHEL2016-06-24