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

Pump, Infusion, Insulin (LZG) (5) Automated Insulin Dosing , Threshold Suspend (OZO) (3) Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (OYC) (2) Alternate Controller Enabled Insulin Infusion Pump (QFG) (1)

Premarket Exempt

No Yes

Clear

t:slim X2 Insulin Pump with Basal-IQ - 00853052007288 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Basal-IQ, Replacement, 6.0

Device Class : 3

Duns Number: 827900809

Premarket Exempt : No

Product Code : OZO

Prescription Use : Yes

Device Count : 1

t:slim X2 5.0 Insulin Pump - 00853052007295 Catalog Number :

Device Description : t:slim X2 5.0 Insulin Pump, Reconditioned

Device Class : 3

Duns Number: 827900809

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump with Basal-IQ - 00853052007301 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Basal-IQ, Reconditioned, 6.0

Device Class : 3

Duns Number: 827900809

Premarket Exempt : No

Product Code : OZO

Prescription Use : Yes

Device Count : 1

t:slim X2 5.0 Insulin Pump - 00853052007318 Catalog Number :

Device Description : t:slim X2 5.0 Insulin Pump, Refurbished

Device Class : 3

Duns Number: 827900809

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump with Basal-IQ - 00853052007325 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Basal-IQ, Refurbished, 6.0

Device Class : 3

Duns Number: 827900809

Premarket Exempt : No

Product Code : OZO

Prescription Use : Yes

Device Count : 1

t:slim Cartridge, t:lock, 2 Pack - 00853052007479 Catalog Number :

Device Description : t:slim Cartridge, t:lock, 2 Pack

Device Class :

Duns Number: 827900809

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 2

t:flex Cartridge, t:lock, 10 Pack - 00853052007493 Catalog Number :

Device Description : t:flex Insulin Pump Cartridges, t:lock, 10 pack

Device Class :

Duns Number: 827900809

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 10

t:flex Cartridge, t:lock, 2 Pack - 00853052007509 Catalog Number :

Device Description : t:flex Insulin Pump Cartridges, t:lock, 2 pack

Device Class :

Duns Number: 827900809

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 2

t:slim Cartridge, t:lock, 10 Pack - 00853052007516 Catalog Number :

Device Description : t:slim Cartridge, t:lock, 10 Pack

Device Class :

Duns Number: 827900809

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 10

t:slim Cartridge, t:lock, 10 Pack - 00853052007776 Catalog Number : 1002541

Device Description : t:slim Cartridge, t:lock, 10 Pack

Device Class :

Duns Number: 827900809

Premarket Exempt : No

Product Code : LZG, QFG

Prescription Use : Yes

Device Count : 10

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