INTENSA

Basic Information

• Brand Name: INTENSA
• Primary DI: M368650T2RGH1
• Version / Model: 650-T2-RGH
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-31
• Public Version: 1
• Public Version Date: 2025-11-10
• Public Version Status: New
• Public Device Record Key: 0d2d30e2-6f79-45b5-a4b1-5a3e41572304

Device Description

BLOOD DONOR CHR, RGH ADJ ARMS

Device Characteristics

• Single Use: No
• 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: Yes
• 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
FML	Chair, Blood Donor	General Hospital	880.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10789	Blood donor chair/couch	A mains electricity (AC-powered) device used to position the patient in such a manner that a technician/nurse has easy access to the patient's arm for drawing blood. The armboard, that is attached to the chair, typically has lateral and height adjustments so that the patient's arm can be positioned in a location that is easily accessible to whoever is drawing the blood sample. This chair is electrically motorized and can be adjusted so that the donor can lie in a reclining position.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M368650T2RGH1	HIBCC

Customer Contacts

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