FDA.reportPublic FDA data

Paradigm® REAL-Time Revel™

Primary DI
00613994920591
Brand
Paradigm® REAL-Time Revel™
Company
MEDTRONIC MINIMED, INC.
Model
MMT-723KLNL
Device description
PUMP MMT-723KLNL PRDGM INS V2.4 CL EN LN
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZGPump, infusion, insulin
MDSSensor, glucose, invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZGPump, Infusion, InsulinGeneral Hospital2
MDSSensor, Glucose, InvasiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980022031

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980022031CONTINUOUS GLUCOSE MONITORING SYSTEMMedtronic Minimed1999-06-15MDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994920591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994920591006139949205916139949205910613994920591

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 Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150002375MiniMed AppMMT-80982026-05-25
00199150002382MiniMed AppMMT-80992026-05-25
00199150077380MiniMed FlexMMT-80622026-05-25
00199150021031MiniMed FlexMMT-80702026-05-24
00763000848149MiniMed FlexMMT-80622026-05-21
00763000848156MiniMed FlexMMT-80722026-05-21
00763000990695INFINITY™ Occipitocervical Upper Thoracic System36503152026-03-22
20763000519692Guardian™ 4 SensorMMT-7040MA2023-05-06
20763000413389Guardian™ 4 SensorMMT-7040A2023-05-06
00763000413477Guardian™ 4 SensorMMT-7040B2023-05-05
20763000519685Guardian™ 4 SensorMMT-7040PA2023-05-06
20763000273358MiniMed™ ReservoirMMT-332A2019-09-02
00199150047000MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047024MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047048MiniMed 780G Insulin pumpMMT-18942025-11-08
00199150047055MiniMed 780G Insulin PumpMMT-1894MD2025-11-08
00199150034123SFTWR MMT-6101 AHCL APP 3.1 ANDROIDMMT-61012025-09-26
00199150034130MiniMed Mobile AppMMT-61022025-09-26
00613994757197iPro™2MMT-77412014-09-25
00613994951274iPro™2MMT-77422014-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850037806034PIVOT Insulin Pump ReplacementModular Medical, Inc.LZG2026-05-26
00850037806072PIVOT InserterModular Medical, Inc.LZG2026-05-26
00850037806133PIVOT Supply Kit (1pk)Modular Medical, Inc.LZG2026-05-26
00850037806164Pivot App for iOSModular Medical, Inc.LZG2026-05-26
00850037806089PIVOT Supply Kit (5pk)Modular Medical, Inc.LZG2026-05-18
00850037806140PIVOT Insulin Pump Starter KitModular Medical, Inc.LZG2026-05-18
10385082000009Omnipod DASH PDMInsulet CorporationLZG2025-08-25
00850037806003MODD1 Adhesive Pad, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806027MODD1 Insulin Cartridge, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806041MODD1 Infusion Set, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806096MODD1 PumpModular Medical, Inc.LZG2025-07-11
10850037806000MODD1 Adhesive Pad, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806010MMI App for iOSModular Medical, Inc.LZG2025-07-11
10850037806024MODD1 Insulin Cartridge, 10 PackModular Medical, Inc.LZG2025-07-11
10850037806048MODD1 Infusion Set, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806065MODD1 Supply KitModular Medical, Inc.LZG2025-07-11
00850037806102MODD1 PumpModular Medical, Inc.LZG2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.LZG2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.LZG2025-07-11
10385084000106Omnipod Go Insulin Delivery Device 10U/day PODInsulet CorporationLZG2023-08-18
10385084000151Omnipod Go Insulin Delivery Device 15U/dayInsulet CorporationLZG2023-08-18
10385084000205Omnipod Go Insulin Delivery Device 20U/dayInsulet CorporationLZG2023-08-18
10385084000250Omnipod Go Insulin Delivery Device 25U/dayInsulet CorporationLZG2023-08-18
10385084000304Omnipod Go Insulin Delivery Device 30U/dayInsulet CorporationLZG2023-08-18
10385084000359Omnipod Go Insulin Delivery Device 35U/dayInsulet CorporationLZG2023-08-18
10385084000403Omnipod Go Insulin Delivery Device 40U/dayInsulet CorporationLZG2023-08-18
20385084000103Omnipod Go Insulin Delivery Device 10U/day PODINSULET CORPORATIONLZG2023-08-18
20385084000158Omnipod Go Insulin Delivery Device 15U/dayINSULET CORPORATIONLZG2023-08-18
20385084000202Omnipod Go Insulin Delivery Device 20U/dayINSULET CORPORATIONLZG2023-08-18
20385084000257Omnipod Go Insulin Delivery Device 25U/dayINSULET CORPORATIONLZG2023-08-18