Tablo(R) Hemodialysis System PN-0003000

GUDID 00850001011112

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

OUTSET MEDICAL, INC.

Haemodialysis system, institutional

• Primary Device ID: 00850001011112
• NIH Device Record Key: b6064c95-6f58-4067-a71a-60e9c35946a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tablo(R) Hemodialysis System
• Version Model Number: PN-0003000
• Catalog Number: PN-0003000
• 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	00850001011112 [Primary]

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2019-01-11

Devices Manufactured by OUTSET MEDICAL, INC.

• 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
• 00850001011181 - Tablo(R) Disinfectant Straws: 2020-08-11 Straws for disinfectant bottle
• 00850001011013 - Tablo Cartridge: 2019-06-07
• 10850001011072 - Tablo Cartridge: 2019-06-07 Tablo Cartridge with Needleless Infusion Ports
• 00850001011082 - Tablo Needleless Cartridge, B: 2019-06-07 Tablo Cartridge with Needleless Infusion Ports Type B