Tablo(R) Cartridge

Basic Information

• Brand Name: Tablo(R) Cartridge
• Primary DI: 00850001011143
• Version / Model: PN-0004221
• Company Name: OUTSET MEDICAL, INC.
• Labeler DUNS: 788744477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-11
• Public Version: 4
• Public Version Date: 2020-06-18
• Public Version Status: Update
• Public Device Record Key: f0707176-fec2-40d5-83f8-83f26ec7c49c

Device Description

The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34999	Haemodialysis blood tubing set, single-use	A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850001011143	GS1
Package	10850001011140	GS1	Case	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140841	000
K190793	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a clean, dry, indoor location
• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity