What is FDA product code QFG?

An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.

General Hospital › TherapeuticAlternate Controller Enabled Insulin Infusion Pump

MiniMed Extended Supply Kit

Name: MiniMed Extended Supply Kit
Brand: MiniMed Extended Supply Kit

KIT MMT-445C Reservoir EXT IS 9MM43N

Registry build 21.09.26

2manufacturers in China registered for this device type

2catalogue numbers in this listing

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QFG
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44

Record

Regulatory record for MiniMed Extended Supply Kit
Listed by	Medtronic, Inc., United States
FDA product code	QFG
Device type	Alternate Controller Enabled Insulin Infusion Pump
Device class	Class 2
Regulation	21 CFR 880.5730
Establishment	Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K251032
Record published	2026-07-19

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number
Storage	Storage environment humidity 5 to 95 % RH; Storage environment temperature -20 to 50 °C

Catalogue Numbers

Catalogue numbers for MiniMed Extended Supply Kit
Catalogue number	Size	Status
MMT-445C		In distribution
MMT-445B		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Tandem Mobi Autosoft XC Kit	Tandem Diabetes Care, Inc.	13
t:slim X2 Insulin Pump with Control-IQ+ Technology	Tandem Diabetes Care, Inc.	12
t:slim X2 Insulin Pump with Control-IQ	Tandem Diabetes Care, Inc.	11
t:slim X2 Insulin Pump with Basal-IQ	Tandem Diabetes Care, Inc.	9
Tandem Mobi	Tandem Diabetes Care, Inc.	5
MiniMed Flex	Medtronic Minimed	4
Tandem Mobi Autosoft 30 Kit	Tandem Diabetes Care, Inc.	4
Omnipod 5 Pod	Insulet Corporation	3
Tandem Mobi TruSteel Kit	Tandem Diabetes Care, Inc.	3
Tandem Mobi Cartridge	Tandem Diabetes Care, Inc.	3
MiniMed Flex Starter Kit	Medtronic, Inc.	2
Omnipod 5 Controller APP	Insulet Corporation	2

Showing 12 of 36. All products under Alternate Controller Enabled Insulin Infusion Pump

Recalls Naming This Product

5 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of MiniMed Extended Supply Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medtronic Minimed	510(k) number	2026-07-13	Class II	Process design	Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycem	16
Medtronic Minimed	510(k) number	2026-07-13	Class II	Process design	Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycem	257
Medtronic Minimed	510(k) number	2026-05-27	Class II	Software design	A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by P	778
Medtronic Minimed	510(k) number	2026-02-13	Class II	Device Design	All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectiv	453,144
Medtronic Minimed	510(k) number	2026-01-30	Class II	Software change control	Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to	26,851 pumps

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.