FDA.reportPublic FDA data

Medtronic Simplera™ Sensor

Primary DI
00763000565039
Brand
Medtronic Simplera™ Sensor
Company
MEDTRONIC MINIMED, INC.
Model
MMT-5100JB
Device description
SENSOR MMT-5100JB SIMPLERA 1PK US
Published
2025-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
P160007047

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160007047Guardian Connect systemMedtronic Minimed2018-03-08MDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000565039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000565039007630005650397630005650390763000565039

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
849626338
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
false
Expiration date on label
false
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
00199150047000MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047024MiniMed 780G Insulin PumpMMT-18842025-11-08
00763000960049MiniMed™ 780GMMT-18842025-06-19
00763000960032MiniMed™ 780GMMT-18842025-06-01
00763000924096MiniMed™ 780GMMT-18842024-06-08
00763000758530MiniMed™ 780GMMT-18842023-05-05
00763000974589InPenMMT-80602025-04-29
00763000974596InPenMMT-80612025-04-29
00763000489953InPen Smart Insulin Delivery SystemMMT-80602025-03-08
00763000489960InPen Smart Insulin Delivery SystemMMT-80612025-03-08
00763000827182inpen™MMT-105NNBLNA2024-06-03
00763000827199inpen™MMT-105NNGYNA2024-06-03
00763000827205inpen™MMT-105NNPKNA2024-06-03
00763000827151inpen™MMT-105ELBLNA2024-05-31
00763000827168inpen™MMT-105ELGYNA2024-05-31
00763000827175inpen™MMT-105ELPKNA2024-06-02
00763000924089MiniMed™ 780GMMT-18842024-06-08
00199150001231App ManagerMMT-8097M2026-06-18
00199150038978MiniMed GoMMT-86002026-06-14
00199150038985MiniMed GoMMT-86012026-06-14

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
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
00386270000842Dexcom Replacement Receiver Kit (Medicare)Dexcom, Inc.PQF2018-02-05
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