Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810077214848
• Version / Model: VKDT x10
• Catalog Number: VKDT x10
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-06-28
• Public Version: 1
• Public Version Date: 2022-07-06
• Public Version Status: New
• Public Device Record Key: c255faf9-5c97-445c-ac4d-586891e2181b

Device Description

Disposable Tourniquet 10

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
GAX	TOURNIQUET, NONPNEUMATIC	General, Plastic Surgery	878.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58128	Limb tourniquet, manual, single-use	A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810077216132	GS1
Primary	00810077214848	GS1

Customer Contacts

• Phone: [phone] ext. 204
• Email: [email protected]