Catheter Repair Kit

Basic Information

• Brand Name: Catheter Repair Kit
• Primary DI: 00801741045103
• Version / Model: CRK5
• Catalog Number: CRK5
• Company Name: Bard Access Systems, Inc.
• Labeler DUNS: 044611812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-04
• Public Version: 3
• Public Version Date: 2023-08-16
• Public Version Status: Update
• Public Device Record Key: 64817a3b-1d13-4bce-a46d-8c89c1097c7a

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
65099	Central venous catheter repair kit	A collection of devices intended to repair an in situ central venous catheter by replacing the damaged external (proximal) portion of the catheter. It includes the replacement proximal section of the catheter and devices associated with the adhesion of this section to the catheter portion remaining in situ (e.g., adhesive material, needle, syringe, sleeve); a complete central venous catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20801741045107	GS1	BX	60	In Commercial Distribution
Package	10801741045100	GS1	CA	5	In Commercial Distribution
Primary	00801741045103	GS1

Customer Contacts

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