FDA.reportPublic FDA data

Stelo Biosensor

Primary DI
00386270004338
Brand
Stelo Biosensor
Company
Dexcom, Inc.
Model
9500-174
Device description
Stelo Biosensor
Published
2024-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234070000Stelo Glucose Biosensor SystemDexcom, Inc.2024-03-05SAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386270004338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386270004338003862700043383862700043380386270004338

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial-fluid glucose monitoring system, electrochemicalAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-738-3646techsupport@dexcom.com

Regulatory Flags#

DUNS number
123160736
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00386270005342Dexcom Therapeutic ServicesSW145532026-04-10
00386270005359Dexcom Therapeutic PortalSW144892026-04-10
00386270004857Stelo Glucose Biosensor (2pk)STP-XN-0032025-03-11
00386270004635Dexcom Stelo iOS Mobile AppSW141162024-08-15
00386270004642Dexcom Stelo Android Mobile AppSW141172024-08-15
00386270004659Dexcom Stelo iOS Watch AppSW141312024-08-15
00386270004345Stelo Glucose Biosensor (1pk)STP-XN-0012024-03-26
00386270004383Stelo Glucose Biosensor (2pk)STP-XN-0022024-03-26
00386270004390Stelo Glucose Biosensor (1pk) UPCSTP-XN-0012024-03-26
00386270004406Stelo Glucose Biosensor (2pk) UPCSTP-XN-0022024-03-26
00386270004475Dexcom Follow 5 Android MobileSW142562025-10-10
00386270004482Dexcom Follow 5 iOS MobileSW142552025-10-10
00386270004802Dexcom Follow 5 iOS Watch Mobile AppSW145132025-10-10
00386270000323Dexcom ReceiverMT229492017-04-10
00386270004574Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System95102025-09-09
00386270004727Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemSTE-FT-0162025-09-09
00386270004734Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemSTP-FT-0102025-09-09
00386270004741Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemSTP-FT-0132025-09-09
00386270004758Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemSTP-FT-0112025-09-09
00386270004765Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemSTP-FT-0122025-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013992606Signos Glucose Management SystemSIGNOS, INC.SAF2026-02-24
00357599850005LingoABBOTT DIABETES CARE INCSAF2025-11-17
00386270004857Stelo Glucose Biosensor (2pk)Dexcom, Inc.SAF2025-03-11
00386270004635Dexcom Stelo iOS Mobile AppDexcom, Inc.SAF2024-08-15
00386270004642Dexcom Stelo Android Mobile AppDexcom, Inc.SAF2024-08-15
00386270004659Dexcom Stelo iOS Watch AppDexcom, Inc.SAF2024-08-15
00357599852009LingoABBOTT DIABETES CARE INCSAF2024-07-24
00357599848002LingoABBOTT DIABETES CARE INCSAF2024-07-15
00357599849009LingoABBOTT DIABETES CARE INCSAF2024-07-15
00357599853006LingoABBOTT DIABETES CARE INCSAF2024-07-15
30357599848003LingoABBOTT DIABETES CARE INCSAF2024-07-15
30357599853007LingoABBOTT DIABETES CARE INCSAF2024-07-15
00386270004345Stelo Glucose Biosensor (1pk)Dexcom, Inc.SAF2024-03-26
00386270004383Stelo Glucose Biosensor (2pk)Dexcom, Inc.SAF2024-03-26
00386270004390Stelo Glucose Biosensor (1pk) UPCDexcom, Inc.SAF2024-03-26
00386270004406Stelo Glucose Biosensor (2pk) UPCDexcom, Inc.SAF2024-03-26