Tablo Hemodialysis Concentrate B-100

GUDID 00850001011037

Liquid bicarbonate concentrate, 45X, 1 U.S. gallon

OUTSET MEDICAL, INC.

Haemodialysis concentrate

• Primary Device ID: 00850001011037
• NIH Device Record Key: 2d9c6fb7-4508-4a51-a40f-6bb098781c1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tablo Hemodialysis Concentrate
• Version Model Number: PN-0000831
• Catalog Number: B-100
• 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: true
• 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

• 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 and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing and do not store in excessive heat.
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001011037 [Primary]
GS1	10850001011034 [Package]; Package: Corrugated carton [4 Units]; In Commercial Distribution

FDA Product Code

• KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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