TANDEM DIABETES CARE, INC.

Address:11075 Roselle Street,San Diego,CA,92121,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Alternate Controller Enabled Insulin Infusion Pump (QFG) (6) Calculator, Drug Dose (NDC) (5) Interoperable Automated Glycemic Controller, Insulin Suspend (QJS) (4) Automated Insulin Dosing , Threshold Suspend (OZO) (2) Continuous Glucose Monitor Secondary Display (PJT) (2) Interoperable Automated Glycemic Controller (QJI) (2)

Premarket Exempt

No Yes

Clear

t:slim X2 Insulin Pump with Control-IQ - 00850006613229 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Control-IQ, 7.x, Reconditioned

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : QJI, QFG

Prescription Use : Yes

Device Count : 1

t:connect Mobile Application (Android) - 00850006613267 Catalog Number :

Device Description : t:connect Mobile Application (Android)

Device Class : 2

Duns Number: 827900809

Premarket Exempt : Yes

Product Code : PJT

Prescription Use : No

Device Count : 1

t:connect Mobile Application (iOS) - 00850006613274 Catalog Number :

Device Description : t:connect Mobile Application (iOS)

Device Class : 2

Duns Number: 827900809

Premarket Exempt : Yes

Product Code : PJT

Prescription Use : No

Device Count : 1

t:slim X2 Insulin Pump with Basal-IQ - 00850006613373 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 6.3.x

Device Class : 3

Duns Number: 827900809

Premarket Exempt : No

Product Code : OZO

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump with Basal-IQ - 00850006613380 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 6.3.x, Refurbished

Device Class : 3

Duns Number: 827900809

Premarket Exempt : No

Product Code : OZO

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump with Basal-IQ - 00850006613700 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 6.4.x

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : QFG, QJS, NDC

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump with Basal-IQ - 00850006613717 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Medicare

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : QFG, QJS, NDC

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump with Basal-IQ - 00850006613724 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Replacement

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : QFG, QJS, NDC

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump with Basal-IQ - 00850006613731 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Refurbished Replacement

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : QFG, QJS, NDC

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump with Control-IQ - 00850006613762 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Control-IQ, 7.4.x

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : QFG, QJI, NDC

Prescription Use : Yes

Device Count : 1

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