FDA.reportPublic FDA data

Enlite™ Sensor

Primary DI
00643169646407
Brand
Enlite™ Sensor
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7008B
Device description
SENSOR MMT-7008B ENLITE PLUS 2L 1CL PR
Published
2016-09-09
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
OZOArtificial pancreas device system, threshold suspend

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120010092

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120010092MINIMED 530G SYSTEMMedtronic, Inc.2013-09-26OZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169646407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169646407006431696464076431696464070643169646407

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 Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
1
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
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
00763000337001Guardian™ 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