FDA.reportPublic FDA data

Enlite ®

Primary DI
00643169786738
Brand
Enlite ®
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7008B
Device description
SENSOR MMT-7008B ENLITE PLUS 2L 1CL PR
Published
2017-11-25
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
OZOAutomated insulin dosing , threshold suspend

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120010100
P150001009
P150019027
P150029006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120010100MINIMED 530G SYSTEMMedtronic, Inc.2013-09-26OZO
P150001009MINIMED 630G SYSTEM WITH SMARTGUARD(TM)Medtronic Minimed2016-08-10OZO
P150019027PARADIGM REAL-TIME REVEL SYSTEMMedtronic Minimed2015-12-07MDS
P150029006IPRO2 CGM SYSTEM WITH ENLITE SENSORMedtronic Minimed2016-06-17MDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169786738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169786738006431697867386431697867380643169786738

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
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
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
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
00643169736061MiniMed® 530GMEDTRONIC MINIMED, INC.OZO2017-05-25