K-6 AIRE-TURN ASSIST K-6oemAN

GUDID 00817012031621

Rotation, On-Demand Low Air Loss, Control Unit

KAP MEDICAL

Low-air-loss bed

• Primary Device ID: 00817012031621
• NIH Device Record Key: bc2ebdc7-5a5d-4947-b0b0-a5610b6f4efe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-6 AIRE-TURN ASSIST
• Version Model Number: K-6oemAN
• Catalog Number: K-6oemAN
• Company DUNS: 135241342
• Company Name: KAP MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817012031621 [Primary]

FDA Product Code

• IKZ: Bed, Patient Rotation, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-02
• Device Publish Date: 2024-11-22

Devices Manufactured by KAP MEDICAL

• 00817012031669 - K-3 AIRE-ZONE: 2025-04-14 Wave 2.0, Injection Molded Housing, Battery Backup, Wave/Pulsating, True Low Air Loss, Universal Mattress System, 84" x 36" x 8"
• 00817012031676 - K-Zoem EZ-TURN: 2025-04-14 Lateral Turning, True Low Air Loss, Bariatric Mattress System 80" x 36" x 10", with Air Pad and UK Power Cord.
• 00817012031652 - K-2oemFAMS: 2025-01-20 Alternating Pressure, On-Demand Low Air Loss, Foam Air, Length and Width Expansion Foam Bolsters, Mattress System, 85"~90" x 36"
• 00817012031621 - K-6 AIRE-TURN ASSIST: 2024-12-02Rotation, On-Demand Low Air Loss, Control Unit
• 00817012031621 - K-6 AIRE-TURN ASSIST: 2024-12-02 Rotation, On-Demand Low Air Loss, Control Unit
• 00817012031638 - K-Z EZ-TURN: 2024-12-02 Lateral Turning, True Low Air Loss, Mattress System, 40"x48"x10", 220V AC, with UK Power Cord
• 00817012031645 - K-4 D3X: 2024-12-02 Alternating Pressure, True Low Air Loss, Battery Backup, Mattress System, 80"x36"x8".
• 00817012031607 - K-Z Z-TURN: 2024-09-30 Rotation, Maximum 30 Degree Rotation Angle, AutoSet, True Low Air Loss, Pulsating, Auto Expandable Width and length, Battery Bac
• 00817012031614 - K-Z Z-TURN: 2024-09-30 Rotation, AutoSet, Pulsating, Auto Expandable Width and length, Battery Backup, with EU Power Cord, Control Unit.