Tablo(R) Straws

Basic Information

• Brand Name: Tablo(R) Straws
• Primary DI: 00850001011167
• Version / Model: PN-0004378
• Catalog Number: PN-0004467, PN-0005451
• 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: 9ab63416-624c-4d32-a5be-aa7a79552794

Device Description

Straws, for concentrate bottles

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
32110	Haemodialysis dialysate tubing, single-use	A sterile length of flexible tube, typically made of synthetic polymer material(s), intended to deliver haemodialysis dialysate and/or haemodialysis dialysate components (water, haemodialysis concentrate) to and/or from a haemodialysis machine/system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850001011164	GS1	cardboard box	12	In Commercial Distribution
Primary	00850001011167	GS1
Package	20850001011161	GS1	cardboard box	48	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190793	000