Enlite™ Serter

Primary DI
00643169462724
Brand
Enlite™ Serter
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7510
Device description
LANCET DEVICE MMT-7510 ENLT SNSRTR 2L
Published
2016-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
MDSSensor, glucose, invasive
OYCPump, infusion, insulin, to be used with invasive glucose sensor
OZOArtificial pancreas device system, threshold suspend

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
MDSSensor, Glucose, InvasiveUnknown3
OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose SensorUnknown3
OZOAutomated Insulin Dosing , Threshold SuspendUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120010000MINIMED 530G SYSTEMMedtronic, Inc.2013-09-26OZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169462724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169462724006431694627246431694627240643169462724

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
1
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
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
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