Pronova-O2

Basic Information

• Brand Name: Pronova-O2
• Primary DI: 00860006962203
• Version / Model: 1
• Catalog Number: PTS001
• Company Name: Turn Medical, LLC
• Labeler DUNS: 072629511
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-03
• Public Version: 1
• Public Version Date: 2024-06-11
• Public Version Status: New
• Public Device Record Key: bc44a782-2af4-437b-8c51-d09af7d7cd74

Device Description

Pronova-O2 is a kinetic bed to prevent pressure injuries and to assist in the management of patients experiencing pulmonary distress and/or complications due in part to patient immobility.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
IKZ	Bed, Patient Rotation, Powered	Physical Medicine	890.5225	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37007	Kinetic bed	A mains electricity (AC-powered) bed designed to enable continuous change of the patient's lying position, e.g., it can tilt the entire bed mattress support system (this includes the mattress, the framework that supports the mattress, and the bedding) lengthways, sideways or to a near vertical tilt; the patient will be secured in such extreme position. The bed is used for the treatment of critically ill patients who are immobilized, often during ventilator treatment, in order to prevent oedema, improve circulation, and prevent bedsores; it is also used for patients with severe back problems. It may have an integrated weighing scale.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860006962203	GS1