CATHETER REPAIR KIT

Basic Information

• Brand Name: CATHETER REPAIR KIT
• Primary DI: 00884908039658
• Version / Model: RMS52001
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 8
• Public Version Date: 2020-10-06
• Public Version Status: Update
• Public Device Record Key: 8aea5ede-372e-44f6-a8e6-ca3a14724205
• Distribution End Date: 2020-06-29

Device Description

CATHETER REPAIR KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
NFK	Kit, repair, catheter, hemodialysis	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61345	Arterial/central venous catheterization support/maintenance kit, non-medicated	A collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884908039658	GS1
Package	30884908039659	GS1	inner box	5	Not in Commercial Distribution	2020-06-29
Package	50884908039653	GS1	box	4	Not in Commercial Distribution	2020-06-29

Customer Contacts

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