EndoClot

Basic Information

• Brand Name: EndoClot
• Primary DI: 16972011720516
• Version / Model: EPAC-1T
• Company Name: EndoClot Plus Co.,Ltd.
• Labeler DUNS: 544357082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-18
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 67f207d8-d391-446d-9ba7-f96e4dd905d9

Device Description

EndoClot® Air Compressor Connecting Tube

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYX	Tubing, Pressure And Accessories	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62063	Endoscopic insufflation tubing set, reusable	A collection of flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26972011720513	GS1		10	In Commercial Distribution
Primary	16972011720516	GS1