t:slim X2 Pump, Replacement, Refurb.

GUDID 00853052007240

t:slim X2 Pump, Replacement, Refurb.

TANDEM DIABETES CARE, INC.

Ambulatory insulin infusion pump/blood glucose analyser system
Primary Device ID00853052007240
NIH Device Record Keyd02d9256-ac7a-4744-ac40-d63c46157a22
Commercial Distribution StatusIn Commercial Distribution
Brand Namet:slim X2 Pump, Replacement, Refurb.
Version Model Number1000353
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100853052007240 [Primary]

FDA Product Code

LZGPump, Infusion, Insulin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-03-09

Devices Manufactured by TANDEM DIABETES CARE, INC.

00389152407012 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ 7.x
00389152407111 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ+ 7.x, Medicare
00389152407210 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ+ 7.x, Replacement
00389152407319 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ+ 7.x, Refurbished
00389152559575 - Tandem Mobi Autosoft XC Kit2024-12-31 Autosoft XC, 5"/6mm, 14 pack kit
00389152559773 - Tandem Mobi Autosoft XC Kit2024-12-31 Autosoft XC, 23"/6mm, 14 pack kit
00389152559971 - Tandem Mobi Autosoft XC Kit2024-12-31 Autosoft XC, 23"/13mm, 14 pack kit
00389152386058 - t:slim X2 Cartridge, t:lock, 10 Pack2024-09-09 Cartridge, t:slim, t:lock, 10 Pack

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