9Line

Basic Information

• Brand Name: 9Line
• Primary DI: G0960R86753090
• Version / Model: R-8675309
• Catalog Number: R-8675309
• Company Name: Rising Eagle Medical LLC
• Labeler DUNS: 080145608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-30
• Public Version: 1
• Public Version Date: 2024-02-07
• Public Version Status: New
• Public Device Record Key: 160e5715-26a7-4cf2-8feb-786f9687f8be

Device Description

Disposable SafeDwell Foley Catheter Monitor with Securement BX of 25

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	876.5130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57982	Urinary catheter holder	A device designed to be attached to a patient's body to hold an indwelling urinary catheter line (e.g., Foley) in place. It consists of a wrap or adhesive strip/pad placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip) without creating excessive pressure on it and permitting visual inspection of the site. It is not designed to hold a urine collection bag. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	G0960R86753095	HIBCC	Box	25	In Commercial Distribution
Primary	G0960R86753090	HIBCC