DEVICE: Dexcom G6 Sensor Applicator Assembly (00386270000255)

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Device Record History
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Device Identifier (DI) Information
Dexcom G6 Sensor Applicator Assembly
9500-45
In Commercial Distribution

Dexcom, Inc.
00386270000255
GS1

1
123160736 *Terms of Use
G6 Sensor Applicator Assembly
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
DEN170088 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 36 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
a89e24e1-d6da-4180-8147-e6d286ac6a72
June 10, 2022
5
April 25, 2018
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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
50386270000250 3 00386270000255 In Commercial Distribution BOX
40386270000253 1 00386270000255 In Commercial Distribution BOX
00386270000866 3 00386270000255 In Commercial Distribution BOX
00386270001047 3 00386270000255 In Commercial Distribution Box
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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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