t:slim Cartridge 2 Pack

GUDID 00852162004620

t:slim Cartridge 2 Pack

TANDEM DIABETES CARE, INC.

Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir
Primary Device ID00852162004620
NIH Device Record Key0eada9f1-3352-488b-8627-28deaafd859b
Commercial Distribution StatusIn Commercial Distribution
Brand Namet:slim Cartridge 2 Pack
Version Model Number006638
Company DUNS827900809
Company NameTANDEM DIABETES CARE, INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com
Phone877-801-6901
EmailTandemCares@tandemdiabetes.com

Device Dimensions

Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100852162004620 [Primary]
GS100852162004767 [Unit of Use]

FDA Product Code

LZGPump, Infusion, Insulin

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-11

Devices Manufactured by TANDEM DIABETES CARE, INC.

00389152319513 - t:slim X2 Insulin Pump with Control-IQ Technology2023-12-14 Control-IQ 7.8
00389152319612 - t:slim X2 Insulin Pump with Control-IQ Technology2023-12-14 Control-IQ 7.8
00389152319711 - t:slim X2 Insulin Pump with Control-IQ Technology2023-12-14 Control-IQ 7.8
00389152319810 - t:slim X2 Insulin Pump with Control-IQ Technology2023-12-14 Control-IQ 7.8
00389152000961 - Tandem Mobi Adhesive Sleeve2023-12-13
00389152271910 - Tandem Mobi2023-11-07 Tandem Mobi Pump with Control-IQ, Replacement
00389152000947 - Tandem Mobi Cartridge2023-11-07 Tandem Mobi Cartridge, 2 Pack
00389152286716 - t:slim X2 Insulin Pump with Control-IQ Technology2023-10-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.