AccessGUDID - DEVICE: t:connect Mobile Application, Mobile Bolus Enabled (iOS) (90850018992452)

GUDID

Device Identifier (DI) Information

Brand Name: t:connect Mobile Application, Mobile Bolus Enabled (iOS)
Version or Model: 1007111
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tandem Diabetes Care, Inc.

Primary DI Number: 90850018992452
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827900809 *Terms of Use

Device Description: t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64656	Ambulatory insulin infusion pump software, data-display	A software application intended to allow a patient or caregiver to remotely extract and view data from an electronic ambulatory insulin infusion pump to support treatment monitoring; it is not intended to control pump settings. It is intended to be used on a non-medical computerized device (e.g., smartphone).	Active	false
63804	Ambulatory insulin infusion pump remote control	A portable electronic device designed to remotely control an electronic ambulatory insulin infusion pump or pump/administration unit. It consists of a wireless unit with dedicated software that interfaces with the pump (not included) to control and program pump functions and receive pump status information. It may transmit data to other platforms for recording/analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJT	Continuous Glucose Monitor Secondary Display
QFG	Alternate Controller Enabled Insulin Infusion Pump

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bea82f52-6e54-4892-a0a3-a6aa50e548a4
Public Version Date: November 03, 2023
Public Version Number: 3
DI Record Publish Date: April 15, 2022