Tablo(R) Straws PN-0004467, PN-0005451

GUDID 10850001011164

Straws, for concentrate bottles

OUTSET MEDICAL, INC.

Haemodialysis dialysate tubing, single-use

• Primary Device ID: 10850001011164
• NIH Device Record Key: 9ab63416-624c-4d32-a5be-aa7a79552794
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tablo(R) Straws
• Version Model Number: PN-0004378
• Catalog Number: PN-0004467, PN-0005451
• 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	00850001011167 [Primary]
GS1	10850001011164 [Package]; Contains: 00850001011167; Package: cardboard box [12 Units]; In Commercial Distribution
GS1	20850001011161 [Package]; Contains: 00850001011167; Package: cardboard box [48 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(R) Straws]

• 10850001011164: Straws, for concentrate bottles
• 10850001011133: Straws, for concentrate bottles