Tablo Hemodialysis Console

GUDID 00850001011006

OUTSET MEDICAL, INC.

Haemodialysis system, institutional

• Primary Device ID: 00850001011006
• NIH Device Record Key: 473771a8-6806-4e05-8ac2-1ddf16fd5c07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tablo Hemodialysis Console
• Version Model Number: PN-0000850
• Company DUNS: 788744477
• Company Name: OUTSET MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001011006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140866

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2015-10-23

Devices Manufactured by OUTSET MEDICAL, INC.

• 00850001011259 - Tablo(R) Cartridge: 2024-05-29 Tablo X Cartridge, OMM
• 00850001011297 - TabloCart™ with Prefiltration Drawer: 2024-05-27 Prefiltration Drawer (Packaged), an optional medical device accessory to the Tablo® Hemodialysis System
• 00850001011303 - TabloCart™ with Prefiltration Drawer: 2024-05-27 Prefiltration Drawer, an optional medical device accessory to the Tablo® Hemodialysis System
• 00850001011204 - Tablo(R) Hemodialysis System: 2024-05-07 Tablo Console
• 00850001011273 - Tablo(R) Cartridge: 2024-01-30 Tablo Cartridge, Needleless, X, with Formula Organizer
• 00850001011105 - Tablo Hemodialysis Concentrate: 2020-08-11 Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon
• 10850001011133 - Tablo(R) Straws: 2020-08-11 Straws, for concentrate bottles
• 10850001011164 - Tablo(R) Straws: 2020-08-11 Straws, for concentrate bottles