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, To Be Used With Invasive Glucose Sensor (OYC) (5) Pump, Infusion, Insulin (LZG) (4) Automated Insulin Dosing , Threshold Suspend (OZO) (1)

Premarket Exempt

No Yes

Clear

t:flex Cartridge 2 Pack - 00852162004743 Catalog Number :

Device Description : t:flex Insulin Pump Cartridges 2 pack

Device Class :

Duns Number: 827900809

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 2

t:slim G4 Insulin Pump, Reconditioned - 00852162004750 Catalog Number :

Device Description : Insulin Pump, Reconditioned 4YR Warranty, t:slim G4

Device Class : 3

Duns Number: 827900809

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump - 00852162004781 Catalog Number :

Device Description : t:slim X2 Insulin Pump

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

t:slim X2 Insulin Pump - 00852162004798 Catalog Number :

Device Description : t:slim X2 Insulin Pump, Reconditioned, 4YR Warranty

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

t:slim X2 Cartridge, t:lock, 10 Pack - 00853052007226 Catalog Number :

Device Description : t:slim G4 / X2 Cartridge, t:lock, 10 Pack

Device Class :

Duns Number: 827900809

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 10

t:slim X2 Cartridge, t:lock, 2 Pack - 00853052007233 Catalog Number :

Device Description : t:slim G4 / X2 Cartridge, t:lock, 2 Pack

Device Class :

Duns Number: 827900809

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 2

t:slim X2 Pump, Replacement, Refurb. - 00853052007240 Catalog Number :

Device Description : t:slim X2 Pump, Replacement, Refurb.

Device Class : 2

Duns Number: 827900809

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

t:slim X2 5.0 Insulin Pump - 00853052007257 Catalog Number :

Device Description : t:slim X2 5.0 Insulin Pump

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 - 00853052007264 Catalog Number :

Device Description : t:slim X2 Insulin Pump with Basal-IQ, 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 - 00853052007271 Catalog Number :

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

Device Class : 3

Duns Number: 827900809

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

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