Amplifine

Basic Information

• Brand Name: Amplifine
• Primary DI: 00350224000158
• Version / Model: BD Vacutainer and Torniquet
• Catalog Number: SM-PRP-VT-10
• Company Name: SUNEVA MEDICAL, INC.
• Labeler DUNS: 012844615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-10
• Public Version: 3
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 14dd2cb6-05ed-4db8-acbd-2f959fe6bb6d

Device Description

Amplifine HD PRP convenience kit. Collection Set & Tourniquet, 10 pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	864.9245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61377	Autologous platelet-based product centrifuge tube	A small, cylindrical container intended to temporarily store venous blood and subsequently placed in a centrifuge to produce platelet rich fibrin (PRF) or platelet rich plasma (PRP) for application to the patient from whom the blood was taken (typically for mixing with bone graft to repair bone defects and/or application to skin wounds to accelerate healing and/or achieve haemostasis). It typically includes a lid intended to be pierced with a syringe needle for blood infusion and PRF/PRP withdrawal, clot activator (e.g., silica) and/or filter for isolation of the PRF/PRP, and a rotation mechanism facilitated by centrifugation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00350224000158	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 40 Degrees Celsius