LIVONGO HEALTH, INC

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Filters

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

Lancet, Blood (FMK) (3) System, Test, Blood Glucose, Over The Counter (NBW) (3) Glucose Oxidase, Glucose (CGA) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (2)

Premarket Exempt

No Yes

Clear

Livongo Test Strips - 00853553005004 Catalog Number : OFG00406

Device Description : 1 vial of 50 Test Strips

Device Class : 2

Duns Number: 829984561

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 1

Livongo Blood Glucose Meter - 00853553005011 Catalog Number : FG02062

Device Description : BG300 rev C Blood Glucose Meter, Kaifa DongGuan

Device Class : 2

Duns Number: 829984561

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

In Touch Glucose Control Solutions - 00853553005028 Catalog Number : OFG00140

Device Description : Box of High/Low Control Solution

Device Class : 1

Duns Number: 829984561

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

In Touch Blood Glucose Meter - 00853553005035 Catalog Number : FG00163

Device Description : In Touch BG 200 Blood Glucose Meter with Charger Adapter and USB Cable

Device Class : 2

Duns Number: 829984561

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Livongo Blood Pressure Monitor - 00853553005042 Catalog Number : OFG05191

Device Description : HT900 Device, Cellular Blood Pressure Monitor (4G)

Device Class : 2

Duns Number: 829984561

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Inb Touch Lancing Device - 00853553005059 Catalog Number : OFG00141

Device Description : Box of 1 Lancet Device

Device Class : 2

Duns Number: 829984561

Premarket Exempt : No

Product Code : FMK

Prescription Use : No

Device Count : 1

In Touch Sterile Lancets - 00853553005066 Catalog Number : OFG00142

Device Description : Box of 100 Sterile Lancets

Device Class : 2

Duns Number: 829984561

Premarket Exempt : No

Product Code : FMK

Prescription Use : No

Device Count : 1

Livongo HT900 Welcome Kit - 00853553005073 Catalog Number : KIT05185

Device Description : 1 Livongo Blood Pressure Monitor HT900, 1 Livongo Blood Pressure Cuff, 1 Travel 1 Livongo Blood Pressure Monitor HT900, 1 Livongo Blood Pressure Cuff, 1 Travel Case, 1 User Guide, 1 Quick Start Guide, 4 Duracell AA Alkaline Batteries

Device Class : 2

Duns Number: 829984561

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

In Touch Welcome Kit - 00853553005097 Catalog Number : KIT00145

Device Description : In Touch Blood Glucose Meter BG200, 1 In Touch Control Solution high/low, 3 boxe In Touch Blood Glucose Meter BG200, 1 In Touch Control Solution high/low, 3 boxes of In Touch Test Strips, 1 In Touch Lancing Device, 3 boxes of sterile In Touch Lancets, 1 Carrying Case, 1 Charger, 1 Charger cable, 1 Instructions for Use (English and Spanish), About Guide (English and Spanish)

Device Class : 2

Duns Number: 829984561

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

In Touch Refill Kit - 00853553005103 Catalog Number : KIT00147

Device Description : 6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch hi 6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch high/low Control Solution

Device Class : 1

Duns Number: 829984561

Premarket Exempt : No

Product Code : FMK, JJX, CGA

Prescription Use : No

Device Count : 1

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