K-Z Z-TURN

Basic Information

• Brand Name: K-Z Z-TURN
• Primary DI: 00817012030211
• Version / Model: K-Z-BB-EU-AP-D-MS
• Catalog Number: K-Z-BB-EU-AP-D-MS
• Company Name: KAP MEDICAL
• Labeler DUNS: 135241342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-17
• Public Version: 1
• Public Version Date: 2022-06-27
• Public Version Status: New
• Public Device Record Key: f09244b4-8185-4ecf-9ca7-d2e2d82671de

Device Description

Rotation, Low Air Loss, Battery Backup, Dartex Top Sheet, Mattress System, 80", 36", 10", with EU Power Cord.

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
IKZ	Bed, Patient Rotation, Powered	Physical Medicine	890.5225	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	00817012030211	GS1

Customer Contacts

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