Tablo Hemodialysis Concentrate

Basic Information

• Brand Name: Tablo Hemodialysis Concentrate
• Primary DI: 00850001011105
• Version / Model: PN-0002630
• Catalog Number: A-125
• Company Name: OUTSET MEDICAL, INC.
• Labeler DUNS: 788744477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-03
• Public Version: 1
• Public Version Date: 2020-08-11
• Public Version Status: New
• Public Device Record Key: 40d033c1-4a84-493c-bb04-572626d688dc

Device Description

Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
35849	Haemodialysis concentrate	A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850001011105	GS1
Package	10850001011102	GS1	carboard box	4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190793	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid freezing or storage in excessive heat.
• Type: Storage Environment Temperature
• Temperature Range: 40 – 90 Degrees Fahrenheit