FDA.reportPublic FDA data

MiniMed Reservoir

Primary DI
00643169771437
Brand
MiniMed Reservoir
Company
MEDTRONIC MINIMED, INC.
Model
MMT-326A
Device description
RSVR MMT-326A 10PK PDGM 1.8ML 21L 3YR
Published
2018-07-12
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
FRNPump, infusion
OZPAutomated insulin dosing device system, single hormonal control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
OZPAutomated Insulin Dosing Device System, Single Hormonal ControlUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001828000PARADIGM 1.5ML RESERVOIR, MODEL 326Minimed, Inc.2000-08-18FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40643169771435PackageGS172In Commercial Distribution
00643169771437PrimaryGS10
70643169771436Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4064316977143540643169771435
00643169771437006431697714376431697714370643169771437
7064316977143670643169771436

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump reservoirAn insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
10
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
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
00856038001942IradimedIRADIMED CORP.FRN2026-10-08
10885403519437BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533211BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533273BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533297BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533334BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533426BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403535215BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403542930BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
05060844770014SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770021SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770038SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770045SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770052SAFIRAMEDOVATE LIMITEDFRN2026-10-05
04046955664214B.BRAUNB. BRAUN MEDICAL INC.FRN2026-07-12
04046961034704Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046961034834Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
00199150047000MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.OZP2025-11-08
00199150047024MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.OZP2025-11-08
00199150003686MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960018MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960025MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960049MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
20763000956381Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956400Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956417Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956394Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000960032MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-01
00763000926106MiniMed™ 770GMEDTRONIC MINIMED, INC.OZP2024-07-01