FDA UDI In Commercial Distribution 🇺🇸 United States

Dexcom API

DI: 00386270000668 · Model: 350-0019 · Dexcom, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Dexcom API
Primary DI
00386270000668
Version / Model
350-0019
Company Name
Dexcom, Inc.
Labeler DUNS
123160736
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-09-21
Public Version
4
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
615e35ca-1bf4-41c9-ae60-5472ffe3d701

Device Description

Public API that allows access by authorized third parties to select Dexcom data

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PHV Continuous Glucose Monitor Retrospective Data Analysis Software

GMDN Terms

Code Name
44611 Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Identifiers

Type ID
Primary 00386270000668