| Primary Device ID | 00386270000033 |
| NIH Device Record Key | 41a0bd3b-4ff4-4291-b613-d4e4216d3843 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dexcom G4 Platinum Sensor US |
| Version Model Number | 9500-39 |
| Company DUNS | 123160736 |
| Company Name | Dexcom, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com | |
| Phone | 1-888-738-3646 |
| Techsupport@dexcom.com |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386270000033 [Primary] |
| MDS | Sensor, Glucose, Invasive |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
[00386270000033]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-04 |
| 00386270004635 - Dexcom Stelo iOS Mobile App | 2024-08-23 |
| 00386270004642 - Dexcom Stelo Android Mobile App | 2024-08-23 |
| 00386270004659 - Dexcom Stelo iOS Watch App | 2024-08-23 |
| 00386270004550 - Dexcom G7 GSS (1) | 2024-06-26 G7 GSS US (1pk) -161 (Government Payor) |
| 00386270004338 - Stelo Biosensor | 2024-04-03 Stelo Biosensor |
| 00386270004345 - Stelo Glucose Biosensor (1pk) | 2024-04-03 Stelo Glucose Biosensor US (1pk) |
| 00386270004383 - Stelo Glucose Biosensor (2pk) | 2024-04-03 Stelo Glucose Biosensor US (2pk) |
| 00386270004390 - Stelo Glucose Biosensor (1pk) UPC | 2024-04-03 Stelo Glucose Biosensor US (1pk) |