Guardian™ Sensor (3)

Primary DI
00763000337001
Brand
Guardian™ Sensor (3)
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7020A
Device description
SENSOR MMT-7020A GS3 5PK 2L US
Published
2020-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZOAutomated insulin dosing , threshold suspend

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZOAutomated Insulin Dosing , Threshold SuspendUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160007036

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160007036Guardian Connect systemMedtronic Minimed2018-03-08MDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000337005PrimaryGS10
00763000337001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300033700520763000337005
00763000337001007630003370017630003370010763000337001

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous glucose monitoring system sensorA sterile, needle-like device 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. Ittypically 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 of time before being discarded (single-use).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
5
DM exempt
true
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
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
00643169455535ENLiTE™MEDTRONIC MINIMED, INC.OZO2023-07-20
00763000391041Guardian™ Link (3)MEDTRONIC XOMED, INC.OZO2020-10-26
00763000391065Guardian™ Link (3)MEDTRONIC MINIMED, INC.OZO2020-10-26
00763000389024Guardian ™ Link (3)MEDTRONIC XOMED, INC.OZO2020-09-06
00763000400620Guardian™ Link (3)MEDTRONIC MINIMED, INC.OZO2020-09-06
00763000337049Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-11
20763000337005Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-10
00763000395858MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2020-07-06
00763000367091MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2020-05-18
00763000341923One-press SerterMEDTRONIC MINIMED, INC.OZO2020-05-16
00763000367053MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2020-05-16
00763000367060MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2020-05-16
00850006613373t:slim X2 Insulin Pump with Basal-IQTandem Diabetes Care, Inc.OZO2020-02-04
00850006613380t:slim X2 Insulin Pump with Basal-IQTandem Diabetes Care, Inc.OZO2020-02-04
00763000317591MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317607MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317614MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317621MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000316631MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316648MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316655MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316662MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316679MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316686MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
10301937550154CONTOUR®NEXTASCENSIA DIABETES CARE US INC.OZO2019-08-30
00763000283445MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2019-08-29
00763000256807MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-05-25
00763000256814MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-05-25
00763000256838MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2019-05-25
00763000190439MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-03-11