175IBLSSC

Basic Information

• Brand Name: 175IBLSSC
• Primary DI: 08053323800026
• Version / Model: 175IBLSSC
• Company Name: ELCAM MEDICAL ITALY SPA
• Labeler DUNS: 513976688
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-26
• Public Version: 3
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: 137d93aa-4323-424e-9eb6-22cc89522633

Device Description

Catheter Injection port

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
GCE	Adaptor, Catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16858	Catheter injection port	A device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. It is also intended to be used as a heparin lock by keeping the heparin flush solution in the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28053323800020	GS1		1000	In Commercial Distribution
Package	18053323800023	GS1		100	In Commercial Distribution
Primary	08053323800026	GS1

Premarket Submissions

Submission Number	Supplement Number
K855039	000