FDA.reportPublic FDA data

Dexcom Therapeutic Services

Primary DI
00386270005342
Brand
Dexcom Therapeutic Services
Company
Dexcom, Inc.
Model
SW14553
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRXContinuous Glucose Monitor Informed Insulin Dose Calculator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRXContinuous Glucose Monitor Informed Insulin Dose CalculatorClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386270005342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386270005342003862700053423862700053420386270005342

GMDN Terms#

Term, Definition table
TermDefinition
Home pharmaceutical management support softwareA software package intended to be used by patients at home, and healthcare professionals in a clinical setting, to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their physical and laboratory data. It is intended to be used on a non-medical computerized device (e.g., to be used on mobile devices at point-of-care); it is not intended to support anaesthesia administration.

Contacts#

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

Regulatory Flags#

DUNS number
123160736
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
00386270005359Dexcom Therapeutic PortalDexcom, Inc.QRX2026-04-10
10385083000459Omnipod 5 Controller APPInsulet CorporationQRX2025-12-01
10385083000336Omnipod 5 Controller APPInsulet CorporationQRX2024-07-22
10385083000503Omnipod 5 Starter Kit Insulet CorporationQRX2024-02-22
10385083000565Omnipod 5 Controller APPInsulet CorporationQRX2024-02-22
10385081120302Omnipod 5 Controller APPInsulet CorporationQRX2022-02-25
10385083000022Omnipod 5 Controller Insulet CorporationQRX2022-02-25