AccessGUDID - DEVICE: t:slim X2 Insulin Pump with Basal-IQ (00850006613731)

GUDID

Device Identifier (DI) Information

Brand Name: t:slim X2 Insulin Pump with Basal-IQ
Version or Model: 1006379
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tandem Diabetes Care, Inc.

Primary DI Number: 00850006613731
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827900809 *Terms of Use

Device Description: t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Refurbished Replacement

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?
51083	Ambulatory insulin infusion pump/blood glucose analyser system	An assembly of battery-powered portable devices designed to deliver insulin and to measure blood glucose as an aid in the management of diabetes mellitus for a patient requiring insulin. It consists of a portable electronic insulin pump that provides continuous subcutaneous delivery of insulin at set and variable rates, and a wireless microprocessor remote controller that interfaces with the pump to control pump functions and receive pump status information. The controller also incorporates a blood glucose meter and built-in test strip port for the quantitative measurement of glucose in fresh capillary blood.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QFG	Alternate Controller Enabled Insulin Infusion Pump
QJS	Interoperable Automated Glycemic Controller, Insulin Suspend
NDC	Calculator, Drug Dose

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
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e1be897e-e71e-401d-89d7-462e06a51382
Public Version Date: May 04, 2023
Public Version Number: 2
DI Record Publish Date: May 18, 2021