Mini Telemetry System

GUDID 00840682117128

WIPRO GE HEALTHCARE PRIVATE LIMITED

Cardiotocography telemetric monitoring system
Primary Device ID00840682117128
NIH Device Record Keyca6fe679-ee1d-4f22-8b68-910415df91d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMini Telemetry System
Version Model Number2051440-002
Company DUNS650140403
Company NameWIPRO GE HEALTHCARE PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(414)355-5000
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682117128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGMSYSTEM, MONITORING, PERINATAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-10
Device Publish Date2016-06-24

On-Brand Devices [Mini Telemetry System]

008406821171662051440-001
008406821171282051440-002
008406821170672051440-004
008406821170122051440-003
008406821169922051444-004
008406821171732051444-001
008406821171112051444-003
008406821170812051444-002

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