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
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• Phone: 844.698.2256
• Email: TechnicalService@outsetmedical.com
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 98 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Clean, dry, indoor location
• Storage Environment Temperature: Between -25 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• 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

On-Brand Devices [Tablo(R) Hemodialysis System]

• 00850001011112: The Tablo System is indicated for use in patients with acute and/or chronic renal failure, with
• 00850001011204: Tablo Console
• 00850001011358: Tablo Console
• 00850001011341: Tablo Console
• 00850001011266: Tablo Console