Tablo(R) Disinfectant Straws PN-0004675

GUDID 00850001011181

Straws for disinfectant bottle

OUTSET MEDICAL, INC.

Haemodialysis dialysate tubing, single-use

• Primary Device ID: 00850001011181
• NIH Device Record Key: a5eb5e9a-7243-477e-a90a-984261b5bc17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tablo(R) Disinfectant Straws
• Version Model Number: PN-0004681
• Catalog Number: PN-0004675
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001011174 [Primary]
GS1	00850001011181 [Package]; Contains: 00850001011174; Package: cardboard box [5 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

Devices Manufactured by OUTSET MEDICAL, INC.

• 00850001011259 - Tablo(R) Cartridge: 2024-05-29 Tablo X Cartridge, OMM
• 00850001011297 - TabloCart™ with Prefiltration Drawer: 2024-05-27 Prefiltration Drawer (Packaged), an optional medical device accessory to the Tablo® Hemodialysis System
• 00850001011303 - TabloCart™ with Prefiltration Drawer: 2024-05-27 Prefiltration Drawer, an optional medical device accessory to the Tablo® Hemodialysis System
• 00850001011204 - Tablo(R) Hemodialysis System: 2024-05-07 Tablo Console
• 00850001011273 - Tablo(R) Cartridge: 2024-01-30 Tablo Cartridge, Needleless, X, with Formula Organizer
• 00850001011105 - Tablo Hemodialysis Concentrate: 2020-08-11 Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon
• 10850001011133 - Tablo(R) Straws: 2020-08-11 Straws, for concentrate bottles
• 10850001011164 - Tablo(R) Straws: 2020-08-11 Straws, for concentrate bottles