AccessGUDID - DEVICE: t:slim G4 Cartridge 2 Pack (00852162004422)

GUDID

Device Identifier (DI) Information

Brand Name: t:slim G4 Cartridge 2 Pack
Version or Model: 007527
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tandem Diabetes Care, Inc.

Primary DI Number: 00852162004422
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 827900809 *Terms of Use

Device Description: The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions.

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:	Yes
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?
35838	Ambulatory insulin infusion pump reservoir	An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OYC	Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P140015	000
P140015	001
P140015	002
P140015	003
P140015	004
P140015	005
P140015	013
P140015	014
P140015	019

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: d3c0ac5d-cce0-4898-9513-5f36b91e1a26
Public Version Date: May 04, 2023
Public Version Number: 4
DI Record Publish Date: December 08, 2015