Tablo Hemodialysis Concentrate A-225

GUDID 10850001011041

Liquid acid concentrate, 45X, 2K, 2.5Ca, 1 U.S. gallon

OUTSET MEDICAL, INC.

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• Primary Device ID: 10850001011041
• NIH Device Record Key: 3ac382b0-8280-49fb-8701-d91359eaadc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tablo Hemodialysis Concentrate
• Version Model Number: PN-0000832
• Catalog Number: A-225
• 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
• 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
• 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

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• 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
• 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
• 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	00850001011044 [Primary]
GS1	10850001011041 [Package]; Contains: 00850001011044; Package: Corrugated carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843963

FDA Product Code

• FKQ: System, Dialysate Delivery, Central Multiple Patient

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: 2019-02-13
• Device Publish Date: 2016-01-29

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