Dexcom Clarity
GUDID 00038270000451
Data Manager Software
Dexcom, Inc.
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| Primary Device ID | 00038270000451 |
| NIH Device Record Key | c9f749ea-bdd5-4ada-870c-8345179c514d |
| Commercial Distribution Discontinuation | 2019-10-16 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Dexcom Clarity |
| Version Model Number | 350-0011 |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00038270000451 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN140016
FDA Product Code
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-09-09 |
| Device Publish Date | 2016-12-20 |
Devices Manufactured by Dexcom, Inc.
| 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) |
| 00386270004406 - Stelo Glucose Biosensor (2pk) UPC | 2024-04-03 Stelo Glucose Biosensor US (2pk) |
| 00386270000378 - Dexcom G7 AR Overlay 10-Pack | 2024-02-26 G7 AR Overlay 10-Pack |
| 00386270004017 - Dexcom G7 Overpatch 10 Pack | 2024-02-26 Dexcom G7 Overpatch 10 Pack |
| 00386270003478 - Dexcom G7 Sample Pack (155) | 2023-09-07 G7 Sample Pack US (1pk) - 155 |
Trademark Results [Dexcom Clarity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DEXCOM CLARITY 86438950 4856753 Live/Registered |
DexCom, Inc. 2014-10-29 |
 DEXCOM CLARITY 85475918 4846261 Live/Registered |
DexCom, Inc. 2011-11-17 |
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