TabloCart™ with Prefiltration Drawer

GUDID 00850001011297

Prefiltration Drawer (Packaged), an optional medical device accessory to the Tablo® Hemodialysis System

OUTSET MEDICAL, INC.

Combination water purification system

• Primary Device ID: 00850001011297
• NIH Device Record Key: b912ab2d-8e92-476f-a1cc-97e7687cf89b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TabloCart™ with Prefiltration Drawer
• Version Model Number: PN-0006988
• Company DUNS: 788744477
• Company Name: OUTSET MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001011297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232776

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

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: 2024-05-27
• Device Publish Date: 2024-05-17

On-Brand Devices [TabloCart™ with Prefiltration Drawer]

• 00850001011303: Prefiltration Drawer, an optional medical device accessory to the Tablo® Hemodialysis System
• 00850001011297: Prefiltration Drawer (Packaged), an optional medical device accessory to the Tablo® Hemodialysi