Summit International

Basic Information

• Brand Name: Summit International
• Primary DI: B346SMCE60151
• Version / Model: SMCE-60.1.5
• Catalog Number: SMCE-60.1.5
• Company Name: DRAGON HEART MEDICAL, INC.
• Labeler DUNS: 841522985
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-03
• Public Version: 1
• Public Version Date: 2021-05-11
• Public Version Status: New
• Public Device Record Key: 4cf013e9-d2cc-49fa-86df-238242c43f83
• Distribution End Date: 2024-04-30

Device Description

60" COILED EXT SET, ID1.5xOD2.5MM

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: Yes
• 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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B346SMCE60151	HIBCC