Qlinch Securement Band

Basic Information

• Brand Name: Qlinch Securement Band
• Primary DI: 20634624100606
• Version / Model: QSB0060
• Company Name: QUEST MEDICAL INC
• Labeler DUNS: 041810693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2020-04-08
• Public Version: 1
• Public Version Date: 2020-04-16
• Public Version Status: New
• Public Device Record Key: bb06bb7b-5a67-4383-b975-a45b201e0655

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: 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
PUK	Administration Set Securement Device	General Hospital	880.5210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62137	Medical/surgical interventional tube/cable securement clip, single-use	A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00634624100602	GS1
Primary	20634624100606	GS1