Tablo Hemodialysis Concentrate A-125

GUDID 00850001011105

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

OUTSET MEDICAL, INC.

Haemodialysis concentrate

• Primary Device ID: 00850001011105
• NIH Device Record Key: 40d033c1-4a84-493c-bb04-572626d688dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tablo Hemodialysis Concentrate
• Version Model Number: PN-0002630
• Catalog Number: A-125
• 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: true
• Serial Number: false
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing or storage in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001011105 [Primary]
GS1	10850001011102 [Package]; Package: carboard box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190793

FDA Product Code

• FJK: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-11
• Device Publish Date: 2020-08-03

On-Brand Devices [Tablo Hemodialysis Concentrate]

• 10850001011058: Liquid acid concentrate, 45X, 3K, 2.5Ca, 1 U.S. gallon
• 10850001011041: Liquid acid concentrate, 45X, 2K, 2.5Ca, 1 U.S. gallon
• 00850001011037: Liquid bicarbonate concentrate, 45X, 1 U.S. gallon
• 00850001011105: Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon