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Pronova-O2

FDA UDI

Class II (US FDA UDI)

by Turn Medical, Llc

Identity

Trade Name
Pronova-O2 FDA UDI
Generic Name
Kinetic bed FDA UDI
Device Name
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. FDA UDI
Model / Reference
1 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
PTS001 FDA UDI
Primary DI / UDI-DI
00860006962203 FDA UDI
FDA Product Code
IKZ FDA UDI
GMDN Term
Kinetic bed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5225 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Kinetic bed

Pronova-O2 by Turn Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Kinetic bed.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Turn Medical, Llc

Sources (1)

  • FDA UDI bc44a782-2af4-437b-8c51-d09af7d7cd74 34 fields · synced May 29, 2026