K-3oem EZ-AIRE

Basic Information

• Brand Name: K-3oem EZ-AIRE
• Primary DI: 00817012023527
• Version / Model: K-3oem 220V
• Catalog Number: K-3oem
• Company Name: KAP MEDICAL
• Labeler DUNS: 135241342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-06
• Public Version: 1
• Public Version Date: 2020-04-14
• Public Version Status: New
• Public Device Record Key: 299117cb-4418-4ba6-a831-2e1957d3cdf2

Device Description

K-3oem True Low Air Loss with Pulsating Wave Therapy Control Unit

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: 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
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	890.5170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17593	Low-air-loss bed	A mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817012023527	GS1

Customer Contacts

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