t:slim X2 5.x Insulin Pump

GUDID 00853052007981

t:slim X2 5.x Insulin Pump, Replacement, Refurbished

TANDEM DIABETES CARE, INC.

Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system
Primary Device ID00853052007981
NIH Device Record Key34b6ec6f-f058-436e-82db-dd9592b544ef
Commercial Distribution StatusIn Commercial Distribution
Brand Namet:slim X2 5.x Insulin Pump
Version Model Number1003808
Company DUNS827900809
Company NameTANDEM DIABETES CARE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100853052007981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-26
Device Publish Date2021-05-18

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