FDA.reportPublic FDA data

Mini Telemetry System

Primary DI
00840682117012
Brand
Mini Telemetry System
Company
WIPRO GE HEALTHCARE PRIVATE LIMITED
Model
2051440-003
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
HGMSYSTEM, MONITORING, PERINATAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110556000MINI TELEMETRY SYSTEMWipro GE Healthcare Private, Ltd.2011-07-19HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682117012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682117012008406821170128406821170120840682117012

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotocography telemetric monitoring systemAn assembly of devices intended to be used to continuously measure and wirelessly transmit foetal heart rate and uterine contraction signals from a patient to a cardiotocograph/monitor. It typically consists of wireless patient worn transducers/electrodes (e.g., leads and electrodes or Doppler ultrasound transducer plus pressure transducer) with appropriate transmitting capability and a receiver unit; the cardiotocograph/monitor is not included. The system is typically used for ambulatory patients who require continuous monitoring before delivery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
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

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
00840682142564ULTRASOUND TRANSDUCERNA21083462018-11-01
00840682142571TOCO TRANSDUCERNA21083472018-11-01
00840682143240Coro - Round MECG cable AHAMECG12018-10-29
00840682116992Mini Telemetry System2051444-0042016-06-24
00840682117067Mini Telemetry System2051440-0042016-06-24
00840682117128Mini Telemetry System2051440-0022016-06-24
00840682117166Mini Telemetry System2051440-0012016-06-24

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