FDA.reportPublic FDA data

Dexcom Replacement Receiver Kit (Medicare)

Primary DI
00386270000842
Brand
Dexcom Replacement Receiver Kit (Medicare)
Company
Dexcom, Inc.
Model
STR-MD-001
Device description
Replacement Receiver Kit (Medicare)
Published
2018-02-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQFSensor, Glucose, Invasive, Non-Adjunctive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQFSensor, Glucose, Invasive, Non-AdjunctiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120005050

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120005050DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEMDexcom, Inc.2012-10-05MDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386270000842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386270000842003862700008423862700008420386270000842

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000721350Simplera™MEDTRONIC MINIMED, INC.PQF2025-07-08
00763000721367Simplera™MEDTRONIC MINIMED, INC.PQF2025-07-08
20763000565026Simplera™ SensorMEDTRONIC MINIMED, INC.PQF2025-03-17
20763000565040Medtronic Simplera™ SensorMEDTRONIC MINIMED, INC.PQF2025-03-17
20763000829579Simplera™ SensorMEDTRONIC MINIMED, INC.PQF2025-03-17
20763000829654Simplera™ SensorMEDTRONIC MINIMED, INC.PQF2025-03-17
00763000565039Medtronic Simplera™ SensorMEDTRONIC MINIMED, INC.PQF2025-03-17
00763000565022Simplera™ SensorMEDTRONIC MINIMED, INC.PQF2025-03-17
00763000565046Medtronic Simplera™ SensorMEDTRONIC MINIMED, INC.PQF2025-03-17
00763000829575Simplera™ SensorMEDTRONIC MINIMED, INC.PQF2025-03-17
00763000829650Simplera™ SensorMEDTRONIC MINIMED, INC.PQF2025-03-17
20386270000327Dexcom G5 Touchscreen ReceiverDexcom, Inc.PQF2018-03-29
00386270000859Dexcom Receiver Kit (Medicare)Dexcom, Inc.PQF2018-02-05
00386270000293Dexcom G5 Mobile Android AppDexcom, Inc.PQF2017-06-08
10386270000320Dexcom Receiver KitDexcom, Inc.PQF2017-04-10
30386270000324Dexcom Replacement Receiver KitDexcom, Inc.PQF2017-04-10
00386270000323Dexcom ReceiverDexcom, Inc.PQF2017-04-10
00386270000606Dexcom G5 Mobile Receiver Kit (Medicare)Dexcom, Inc.PQF2017-04-04
00386270000613Dexcom G5 Mobile Replacement Receiver Kit (Medicare)Dexcom, Inc.PQF2017-04-04
00386270000620Dexcom G5 Mobile Transmitter Kit (Medicare)Dexcom, Inc.PQF2017-04-04