Tablo Needleless Cartridge, B CART-201

GUDID 00850001011082

Tablo Cartridge with Needleless Infusion Ports Type B

OUTSET MEDICAL, INC.

Haemodialysis blood tubing set, single-use

• Primary Device ID: 00850001011082
• NIH Device Record Key: 8de71e08-d315-41b7-b471-9a0dea9220fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tablo Needleless Cartridge, B
• Version Model Number: PN-0002572
• Catalog Number: CART-201
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, indoor location
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001011082 [Primary]
GS1	10850001011089 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140841

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2017-06-05

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