AccessGUDID - DEVICE: t:slim X2 Insulin Pump with Control-IQ+ Technology (00389152407111)

GUDID

Device Identifier (DI) Information

Brand Name: t:slim X2 Insulin Pump with Control-IQ+ Technology
Version or Model: 1014071
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tandem Diabetes Care, Inc.

Primary DI Number: 00389152407111
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827900809 *Terms of Use

Device Description: Control-IQ+ 7.x, Medicare

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
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?
64891	Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm	A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
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: eb38fb6f-c661-4b0b-9b7a-0ee0b298e8dd
Public Version Date: January 30, 2025
Public Version Number: 2
DI Record Publish Date: January 17, 2025