Tablo(R) Hemodialysis System

Basic Information

• Brand Name: Tablo(R) Hemodialysis System
• Primary DI: 00850001011204
• Version / Model: PN-0006000
• Company Name: OUTSET MEDICAL, INC.
• Labeler DUNS: 788744477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-17
• Public Version: 1
• Public Version Date: 2020-06-25
• Public Version Status: New
• Public Device Record Key: 15f9f991-07d4-45f4-8a46-3f8519f87306

Device Description

Tablo Console

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	876.5860	2
FIP	Subsystem, Water Purification	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58131	Haemodialysis system, institutional/home-use	An assembly of mains electricity (AC-powered) devices designed to perform haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. The system typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850001011204	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K200741	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 98 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 98 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius