What is FDA product code PJT?

The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring

MiniMed™ Mobile · Continuous Glucose Monitor Secondary Display → Clinical Chemistry

Name: MiniMed™ Mobile
Brand: MiniMed™ Mobile

1manufacturer

3catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Hong Kong.

Chinese manufacturers registered for FDA product code PJT
Manufacturer	City	Province	Registered as	Device types
Skytech Electronics (HK) Limited	Tsim Sha Tsui	Hong Kong	Contract manufacturer	5

Record

Regulatory record for MiniMed™ Mobile
Listed by	Medtronic Minimed, United States
FDA product code	PJT
Device type	Continuous Glucose Monitor Secondary Display
Device class	Class 2
Regulation	21 CFR 862.1350
Establishment	Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2023-11-27
Record revised	2023-08-18 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for MiniMed™ Mobile
Catalogue number	Size	Status
MMT-6102		In distribution
MMT-6102		In distribution
MMT-6102		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
t:connect Mobile Application, Mobile Bolus Enabled (Android)	Tandem Diabetes Care, Inc.	2
Welldoc App for Diabetes in Pregnancy and Insulin Pump Users	Welldoc	2
t:connect Mobile Application (Android)	Tandem Diabetes Care, Inc.	1
Eversense NOW Mobile App Android	Senseonics, Inc.	1
Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users	Welldoc	1
Dexcom Follow App for Android	Dexcom, Inc.	1
LibreLinkUp	Abbott Diabetes Care Limited	1
Dexcom Follow 5 Android Mobile	Dexcom, Inc.	1
Dexcom Follow App for iOS	Dexcom, Inc.	1
t:connect Mobile Application (iOS)	Tandem Diabetes Care, Inc.	1
Eversense® NOW Mobile App iOS	Senseonics, Inc.	1
Dexcom Follow 5 iOS Watch Mobile App	Dexcom, Inc.	1

Showing 12 of 13. All products under Continuous Glucose Monitor Secondary Display

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K151236	2015-05-19

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.

MiniMed™ Mobile