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

Clinical Chemistry › Test SystemsContinuous Glucose Monitor Secondary Display

T: Connect Mobile Application (iOS)

Catalogue number 1004128, listed by Tandem Diabetes Care, Inc., United States, under Continuous Glucose Monitor Secondary Display. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

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 t:connect Mobile Application (iOS)
Listed by	Tandem Diabetes Care, Inc., United States
FDA product code	PJT
Device type	Continuous Glucose Monitor Secondary Display
Device class	Class 2
Regulation	21 CFR 862.1350
Establishment	Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2019-12-18
Record revised	2023-11-03 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for t:connect Mobile Application (iOS)
Catalogue number	Size	Status
1004128		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
MiniMed™ Mobile	Medtronic Minimed	3
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
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

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of t:connect Mobile Application (iOS)
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Tandem Diabetes Care, Inc.	UDI-DI	2024-03-05	Class I	Software Design Change	During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain a	85,863 applications

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.