FDA.reportPublic FDA data

ENLITE®

Primary DI
00643169246577
Brand
ENLITE®
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7008B
Device description
SENSOR MMT-7008B ENLITE NFIN US
Published
2014-09-24
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
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
P120010011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120010011MINIMED 530G SYSTEMMedtronic, Inc.2013-09-26OZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169246577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169246577006431692465776431692465770643169246577

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 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
00763000924089MiniMed™ 780GMMT-18842024-06-08
00199150001231App ManagerMMT-8097M2026-06-18
00199150038978MiniMed GoMMT-86002026-06-14
00199150038985MiniMed GoMMT-86012026-06-14
20763000336985Guardian™ Sensor (3)MMT-7020LA2020-10-12
20763000337005Guardian™ Sensor (3)MMT-7020A2020-07-10
20763000358444Guardian™ Sensor (3)MMT-7020PLA2020-10-31
20763000455655Guardian™ Sensor (3)MMT-7020GA2021-04-04
20763000455662Guardian™ Sensor (3)MMT-7020A2021-04-05
20763000455686Guardian™ Sensor (3)MMT-7020PLA2021-04-05
20763000497181Extended ReservoirMMT-3422022-09-09
20763000516233Guardian™ Sensor (3)MMT-7020MLA2021-06-03
20763000565026Simplera™ SensorMMT-5100JA2025-03-17
20763000565040Medtronic Simplera™ SensorMMT-5101N2025-03-17
20763000578804Guardian™ Sensor (3)MMT-7020LA2023-03-27
20763000829579Simplera™ SensorMMT-5100JPA2025-03-17
20763000829654Simplera™ SensorMMT-5101PN2025-03-17
20763000956381Simplera Sync™MMT-5120A2025-06-01
70643169771481MiniMed™ ReservoirMMT-332A2018-05-31
00643169705920Sil-serter™MMT-3852022-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169455535ENLiTE™MEDTRONIC MINIMED, INC.OZO2023-07-20
00643169873834MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2018-02-05
00643169932999MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-11-30
00643169933002MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-11-30
00643169933019MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-11-30
00643169933026MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-11-30
00643169933033MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-11-30
00643169933187MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-11-30
00643169786738Enlite ®MEDTRONIC MINIMED, INC.OZO2017-11-25
00643169736030MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736047MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736078MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736320MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736337MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736344MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736351MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736368MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736375MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736382MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736399MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736405MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736412MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736429MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736436MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736443MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736450MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736467MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736474MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736481MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01
00643169736498MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-06-01