ALN 2in1

Basic Information

• Brand Name: ALN 2in1
• Primary DI: 03760017680127
• Version / Model: RK-2010
• Company Name: A.L.N.
• Labeler DUNS: 272983094
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-26
• Public Version: 1
• Public Version Date: 2018-11-26
• Public Version Status: New
• Public Device Record Key: 72f3ce54-54b6-4022-a837-cfa53dedd828

Device Description

The device is a 2in1 Extraction Kit of ALN Vena Cava Filter including a puncture needle, a J guidewire, a 9F introduction sheath, a dilatator and a pincer catheter 7F.

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	870.3375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45162	Vena cava filter extraction/repositioning kit	A collection of sterile devices designed to perform the percutaneous retrieval or repositioning of an implanted inferior vena cava (IVC) filter. It will typically contain various dedicated catheters with dilating, pushing, and retrieval functions (e.g., gripping claws, loop/lasso) and devices such as needles and guide wires. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760017680127	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163699	000