DEVICE: Dexcom G4 Platinum Sensor US (00386270000033)

Device Identifier (DI) Information

Dexcom G4 Platinum Sensor US
9500-39
In Commercial Distribution

Dexcom, Inc.
00386270000033
GS1

1
123160736 *Terms of Use
Sensor Applicator Assembly Automation
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Percutaneous glucose monitoring system An assembly of portable, battery-powered devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It consists of a sterile, electrochemical, percutaneously-inserted electrode that 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 or clinical setting, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.
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FDA Product Code

[?]
Product Code Product Code Name
MDS Sensor, Glucose, Invasive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P120005 000
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Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

41a0bd3b-4ff4-4291-b613-d4e4216d3843
July 06, 2018
3
September 04, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-888-738-3646
Techsupport@dexcom.com
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