TANDEM DIABETES CARE, INC.

Address:6495 Marindustry Place,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) (10) Calculator, Drug Dose (NDC) (8) Interoperable Automated Glycemic Controller, Insulin Suspend (QJS) (8) Interoperable Automated Glycemic Controller (QJI) (2)

Premarket Exempt

No Yes

Clear

t:slim X2 Insulin Pump with Basal-IQ - 00389152000015 Catalog Number : 1010004

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 6.6.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 - 00389152000022 Catalog Number : 1010005

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 6.6.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 - 00389152000039 Catalog Number : 1010006

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 6.6.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 - 00389152000046 Catalog Number : 1010007

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 6.6.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 - 00389152000077 Catalog Number : 1010009

Device Description : t:slim X2 Insulin Pump with Control-IQ, 7.6.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 Control-IQ - 00389152000084 Catalog Number : 1010010

Device Description : t:slim X2 Insulin Pump with Control-IQ, 7.6.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 Control-IQ - 00389152000091 Catalog Number : 1010011

Device Description : t:slim X2 Insulin Pump with Control-IQ, 7.6.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 Control-IQ - 00389152000107 Catalog Number : 1010012

Device Description : t:slim X2 Insulin Pump with Control-IQ, 7.6.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 - 00850006613205 Catalog Number :

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

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : QFG, QJI

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump with Control-IQ - 00850006613212 Catalog Number :

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

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : QFG, QJI

Prescription Use : Yes

Device Count : 1

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