OUTSET MEDICAL, INC.

Address:3052 Orchard Drive,San Jose,CA,95134,US

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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

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (FJK) (5) Dialyzer, High Permeability With Or Without Sealed Dialysate System (KDI) (2) Subsystem, Water Purification (FIP) (1)

Premarket Exempt

Clear

Tablo(R) Cartridge - 00850001011143 Catalog Number :

Device Description : The Tablo Cartridge is a single use, disposable arterial and venous bloodline se

Device Class :

Duns Number: 788744477

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Tablo(R) Straws - 00850001011167 Catalog Number : PN-0004467, PN-0005451

Device Description : Straws, for concentrate bottles

Device Class :

Duns Number: 788744477

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Tablo(R) Disinfectant Straws - 00850001011174 Catalog Number : PN-0004675

Device Description : Straws for disinfectant bottle

Device Class : 2

Duns Number: 788744477

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Tablo(R) Hemodialysis System - 00850001011204 Catalog Number :

Device Description : Tablo Console

Device Class : 2

Duns Number: 788744477

Premarket Exempt : No

Product Code : KDI, FIP

Prescription Use : Yes

Device Count : 1

Tablo(R) Cartridge - 00850001011211 Catalog Number : PN-0004220

Device Description : Tablo X Cartridge with Needleless Infusion Ports

Device Class : 2

Duns Number: 788744477

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Tablo(R) Cartridge - 00850001011242 Catalog Number : PN-0004220

Device Description : Tablo X Cartridge with Needleless Infusion Ports

Device Class :

Duns Number: 788744477

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Tablo Straws - 20850001011024 Catalog Number : ST-100

Device Class :

Duns Number: 788744477

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 2

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