Primary Device ID | 00386270000668 |
NIH Device Record Key | 615e35ca-1bf4-41c9-ae60-5472ffe3d701 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dexcom API |
Version Model Number | 350-0019 |
Company DUNS | 123160736 |
Company Name | Dexcom, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00386270000668 [Primary] |
PHV | Continuous Glucose Monitor Retrospective Data Analysis Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-09-21 |
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) |