Dexcom G4 Platinum (Pedicatric) Replacement Receiv

GUDID 30386270000102

G4 Platinum (Pediatric) Replacement Receiver Kit Pink

Dexcom, Inc.

Percutaneous glucose monitoring system Percutaneous glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Primary Device ID30386270000102
NIH Device Record Key4685a35d-080d-4408-9557-0dbb4f809f31
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexcom G4 Platinum (Pedicatric) Replacement Receiv
Version Model NumberSTR-KD-PNK
Company DUNS123160736
Company NameDexcom, Inc.
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 Batchtrue
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

Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com
Phone1-888-738-3646
EmailTechsupport@dexcom.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS130386270000102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDSSensor, Glucose, Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-12

On-Brand Devices [Dexcom G4 Platinum (Pedicatric) Replacement Receiv]

30386270000119G4 Platinum (Pediatric) Replacement Receiver Kit Blue
30386270000102G4 Platinum (Pediatric) Replacement Receiver Kit Pink
30386270000072G4 Platinum (Pediatric) Replacement Receiver Kit Black

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.