FDA.reportPublic FDA data

Simplera™ Sensor

Primary DI
20763000565026
Brand
Simplera™ Sensor
Company
MEDTRONIC MINIMED, INC.
Model
MMT-5100JA
Device description
SENSOR MMT-5100JA SIMPLERA 5PK US
Published
2025-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
20763000565026PrimaryGS10
00763000565022Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300056502620763000565026
00763000565022007630005650227630005650220763000565022

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial fluid glucose monitoring system sensorA small, electronic device with micro-needle(s) intended to be inserted percutaneously into interstitial tissue to continuously measure and record interstitial fluid glucose concentrations, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is typically a thin, flexible, needle electrode that uses electrochemical means to convert glucose levels into an electrical signal. It typically has an adhesive covering that holds it to the skin surface, and transmits the signal via a cable or transmitter. This is a single-patient device intended be used for a period before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
5
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150002375MiniMed AppMMT-80982026-05-25
00199150002382MiniMed AppMMT-80992026-05-25
00199150077380MiniMed FlexMMT-80622026-05-25
00199150021031MiniMed FlexMMT-80702026-05-24
00763000848149MiniMed FlexMMT-80622026-05-21
00763000848156MiniMed FlexMMT-80722026-05-21
00763000990695INFINITY™ Occipitocervical Upper Thoracic System36503152026-03-22
20763000519692Guardian™ 4 SensorMMT-7040MA2023-05-06
20763000413389Guardian™ 4 SensorMMT-7040A2023-05-06
00763000413477Guardian™ 4 SensorMMT-7040B2023-05-05
20763000519685Guardian™ 4 SensorMMT-7040PA2023-05-06
20763000273358MiniMed™ ReservoirMMT-332A2019-09-02
00199150047000MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047024MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047048MiniMed 780G Insulin pumpMMT-18942025-11-08
00199150047055MiniMed 780G Insulin PumpMMT-1894MD2025-11-08
00199150034123SFTWR MMT-6101 AHCL APP 3.1 ANDROIDMMT-61012025-09-26
00199150034130MiniMed Mobile AppMMT-61022025-09-26
00613994757197iPro™2MMT-77412014-09-25
00613994951274iPro™2MMT-77422014-09-23

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
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
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