FDA.reportPublic FDA data

MiniMed® 530G

Primary DI
00643169507029
Brand
MiniMed® 530G
Company
MEDTRONIC MINIMED, INC.
Model
MMT-751LNAH
Device description
PUMP MMT-751LNAH PRDGM V3.0 PK EN PR LN
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
P120010005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120010005MINIMED 530G SYSTEMMedtronic, Inc.2013-09-26OZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169507029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169507029006431695070296431695070290643169507029

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump, electronicA portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included).

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
false
Serial number
true
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
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
00643169771413MiniMed ReservoirMMT-326A2016-10-03

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