Protekt O2

Basic Information

• Brand Name: Protekt O2
• Primary DI: 05060488570278
• Version / Model: 78004
• Catalog Number: 78004
• Company Name: PROACTIVE MEDICAL PRODUCTS, LLC
• Labeler DUNS: 078582655
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a4eae9ae-a8c2-4228-ab50-8646fc95d6cd

Device Description

PROTEKT O2 CUSHION DRY FLOTATION SEATING 16" HIGH PROFILE

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: Yes
• 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
KIC	Cushion, Flotation	Physical Medicine	890.3175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47477	Air-filled chair cushion	A static-air-inflated pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060488570278	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	4	Inch
Length	16	Inch
Width	16	Inch