AccessGUDID - DEVICE: t:slim X2 Cartridge, t:lock, 2 Pack (00853052007233)

GUDID

Device Identifier (DI) Information

Brand Name: t:slim X2 Cartridge, t:lock, 2 Pack
Version or Model: 1000728
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tandem Diabetes Care, Inc.

Primary DI Number: 00853052007233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 827900809 *Terms of Use

Device Description: t:slim G4 / X2 Cartridge, t:lock, 2 Pack

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	017
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 Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: e8f8b9f7-d140-4b12-8858-3d593a8c578f
Public Version Date: May 04, 2023
Public Version Number: 4
DI Record Publish Date: August 25, 2017