9Line

Basic Information

• Brand Name: 9Line
• Primary DI: G096R929220
• Version / Model: R-92922
• Catalog Number: R-92922
• 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: ba97cd53-7634-4f97-abae-79112f29c4c3

Device Description

Disposable CardiPatch, skin patch over pacemaker site cushion (1 Case of 6 boxes. Each box contains 2 patches)

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FMP	Protector, Skin Pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66981	Pacemaker site protection skin-adherent pad	A skin-adherent device intended to be applied to chest skin over the pocket of an implantable cardiac device (e.g., pacemaker) to protect the area from impact/injury during the recipient’s daily activities. It is in the form of an adhesive cushioned pad made of spongy materials (e.g., foam, gel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	G096R929225	HIBCC	Case	6	In Commercial Distribution
Primary	G096R929220	HIBCC