AccessGUDID - DEVICE: t:slim X2 Insulin Pump with Basal-IQ (00850006613380)

GUDID

Device Identifier (DI) Information

Brand Name: t:slim X2 Insulin Pump with Basal-IQ
Version or Model: 1005706
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tandem Diabetes Care, Inc.

Primary DI Number: 00850006613380
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, 6.3.x, Refurbished

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
OZO	Automated Insulin Dosing , Threshold Suspend

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P180008	000
P180008	001
P180008	002
P180008	003

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: d4a4deb2-67ac-49a0-8197-8eed37966030
Public Version Date: May 04, 2023
Public Version Number: 2
DI Record Publish Date: February 04, 2020