FDA.reportPublic FDA data

Dexcom G5 Transmitter

Primary DI
00386270000224
Brand
Dexcom G5 Transmitter
Company
Dexcom, Inc.
Model
9438-06
Device description
G5 Transmitter
Published
2015-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDSSensor, Glucose, Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDSSensor, Glucose, InvasiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120005033

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120005033DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEMDexcom, Inc.2012-10-05MDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386270000224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386270000224003862700002243862700002240386270000224

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous glucose monitoring systemAn assembly of portable, battery-powered devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It consists of a sterile, electrochemical, percutaneously-inserted electrode that 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 or clinical setting, 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
Serial number
true
Manufacturing 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
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

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Primary DI, Brand, Company table
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00763000399009Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-07-02
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00763000341923One-press SerterMEDTRONIC MINIMED, INC.MDS2020-05-16
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