Pronova-O2

Primary DI
00860006962203
Brand
Pronova-O2
Company
Turn Medical, LLC
Model
1
Catalog number
PTS001
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.
Published
2024-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IKZBed, Patient Rotation, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKZBed, Patient Rotation, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006962203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006962203008600069622038600069622030860006962203

GMDN Terms#

Term, Definition table
TermDefinition
Kinetic bedA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
072629511
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817012031850K-6 TURN-ZONEKAP MEDICALIKZ2026-01-16
00817012031829K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-10-10
00817012031843K-Zoem EZ-TURNKAP MEDICALIKZ2025-10-10
00817012031775K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031782K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031799K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031737K-6 TURN-ZONEKAP MEDICALIKZ2025-09-04
00817012022179K-Z ZM ZMattKAP MEDICALIKZ2025-06-27
00817012031676K-Zoem EZ-TURNKAP MEDICALIKZ2025-04-04
00817012031621K-6 AIRE-TURN ASSISTKAP MEDICALIKZ2024-11-22
00817012031638K-Z EZ-TURNKAP MEDICALIKZ2024-11-22
00817012031607K-Z Z-TURNKAP MEDICALIKZ2024-09-20
00817012031614K-Z Z-TURNKAP MEDICALIKZ2024-09-20
B414PAR3A3FXX0The Freedom BedProBed Medical Technologies IncIKZ2024-09-05
00817012031577K-Z ZM ZMattKAP MEDICALIKZ2024-08-23
00817012031584K-Zoem EZ-TURNKAP MEDICALIKZ2024-08-23
00817012031591K-Z ZM ZMattKAP MEDICALIKZ2024-08-23
00817012031492K-Z ZM ZMattKAP MEDICALIKZ2024-07-19
00817012031546K-Z Z-TURNKAP MEDICALIKZ2024-07-19
00860011685609SideLyerTHE SIDE LYER COMPANY, LLCIKZ2024-04-29
00817012031355K-6 TURN-ZONEKAP MEDICALIKZ2024-01-19
00817012031362K-6 TURN-ZONEKAP MEDICALIKZ2024-01-19
00860004936817EasyShiftSeneca Devices, Inc.IKZ2024-01-12
00860004936848EasyShiftSeneca Devices, Inc.IKZ2024-01-12
00817012031386K-6 TURN-ZONEKAP MEDICALIKZ2023-11-30
00817012031379K-Z Z-TURNKAP MEDICALIKZ2023-08-11
00817012031348K-6 TURN-ZONEKAP MEDICALIKZ2023-07-14
00817012031164K-Z iTURNKAP MEDICALIKZ2023-06-02
00817012031171K-Z iTURNKAP MEDICALIKZ2023-06-02
00817012031157K-Z Z-TURNKAP MEDICALIKZ2023-03-17