HARVEST®

Basic Information

• Brand Name: HARVEST®
• Primary DI: 05020583514072
• Version / Model: 51407
• Company Name: TERUMO BCT, INC.
• Labeler DUNS: 801679200
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 11
• Public Version Date: 2024-02-08
• Public Version Status: Update
• Public Device Record Key: 8bed1e25-8394-4735-83d0-610c16ed6f53
• Distribution End Date: 2023-11-15

Device Description

Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-60i PRP Procedure Pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
46923	Haematological concentrate system preparation kit, platelet concentration	A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05020583514072	GS1
Package	35020583514073	GS1		3	Not in Commercial Distribution	2023-02-14

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius