FDA.reportPublic FDA data

Stelo Glucose Biosensor, Retail 1-pack

Primary DI
00386270005533
Brand
Stelo Glucose Biosensor, Retail 1-pack
Company
Dexcom, Inc.
Model
STP-XN-010
Device description
Stelo Glucose Biosensor, US Retail 1-pack
Published
2026-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SBHIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386270005533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386270005533003862700055333862700055330386270005533

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.

Regulatory Flags#

DUNS number
123160736
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00386270004338Stelo Biosensor9500-1742024-03-26
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