DEVICE: Dexcom G4 Platinum Sensor US (00386270000033)
Device Identifier (DI) Information
Dexcom G4 Platinum Sensor US
9500-39
In Commercial Distribution
Dexcom, Inc.
9500-39
In Commercial Distribution
Dexcom, Inc.
Sensor Applicator Assembly Automation
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44611 | Percutaneous interstitial-fluid glucose monitoring system, electrochemical |
An assembly of electrically-powered, portable devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MDS | Sensor, Glucose, Invasive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P120005 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit |
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
41a0bd3b-4ff4-4291-b613-d4e4216d3843
June 10, 2022
5
September 04, 2014
June 10, 2022
5
September 04, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-888-738-3646
Techsupport@dexcom.com
Techsupport@dexcom.com