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) System, Dialysate Delivery, Central Multiple Patient (FKQ) (2) Dialysate Concentrate For Hemodialysis (Liquid Or Powder) (KPO) (1) Subsystem, Water Purification (FIP) (1)

Premarket Exempt

Clear

Tablo Hemodialysis Console - 00850001011006 Catalog Number :

Device Class : 2

Duns Number: 788744477

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Tablo Cartridge - 00850001011013 Catalog Number : CART-100

Device Class :

Duns Number: 788744477

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Tablo Hemodialysis Concentrate - 00850001011037 Catalog Number : B-100

Device Description : Liquid bicarbonate concentrate, 45X, 1 U.S. gallon

Device Class :

Duns Number: 788744477

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

Tablo Hemodialysis Concentrate - 00850001011044 Catalog Number : A-225

Device Description : Liquid acid concentrate, 45X, 2K, 2.5Ca, 1 U.S. gallon

Device Class : 2

Duns Number: 788744477

Premarket Exempt : No

Product Code : FKQ

Prescription Use : Yes

Device Count : 1

Tablo Hemodialysis Concentrate - 00850001011051 Catalog Number : A-325

Device Description : Liquid acid concentrate, 45X, 3K, 2.5Ca, 1 U.S. gallon

Device Class : 2

Duns Number: 788744477

Premarket Exempt : No

Product Code : FKQ

Prescription Use : Yes

Device Count : 1

Tablo Cartridge - 00850001011075 Catalog Number : CART-200

Device Description : Tablo Cartridge with Needleless Infusion Ports

Device Class : 2

Duns Number: 788744477

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Tablo Needleless Cartridge, B - 00850001011082 Catalog Number : CART-201

Device Description : Tablo Cartridge with Needleless Infusion Ports Type B

Device Class :

Duns Number: 788744477

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Tablo Hemodialysis Concentrate - 00850001011105 Catalog Number : A-125

Device Description : Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon

Device Class :

Duns Number: 788744477

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Tablo(R) Hemodialysis System - 00850001011112 Catalog Number : PN-0003000

Device Description : The Tablo System is indicated for use in patients with acute and/or chronic rena The Tablo System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute orchronic care facility.

Device Class : 2

Duns Number: 788744477

Premarket Exempt : No

Product Code : FIP, KDI

Prescription Use : Yes

Device Count : 1

Tablo(R) Straws - 00850001011136 Catalog Number :

Device Description : Straws, for concentrate bottles

Device Class : 2

Duns Number: 788744477

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

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