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

• 00817012031720 - K-4oem AIRE-FLOAT: 2025-09-15 Alternating Pressure, Low Air Loss, Mattress System, 84"x36"x8".
• 00817012031737 - K-6 TURN-ZONE: 2025-09-12 Alternating, Rotation, Turn Assist, ON-Demand Low Air Loss, Mattress System, 84"x36"x10".
• 00817012022179 - K-Z ZM ZMatt: 2025-07-07 ISENSE-CLRT, Rotation, IntelliMatt with Auto Sensing Immersion, True Low Air Loss, Expandable Width and length, Battery Backup,
• 00817012031690 - K-4 D3X: 2025-06-23 Alternating Pressure, True Low Air Loss, with Dartex Top Sheet, Mattress System, 80"x 36"x8"
• 00817012031706 - K-4 D3X: 2025-06-23 Alternating Pressure, True Low Air Loss, Bariatric, with Dartex Top Sheet, Mattress System, 84"x48"x10".
• 00817012031713 - K-4 D3X: 2025-06-23 Alternating Pressure, True Low Air Loss, with Dartex Top Sheet, Mattress System, 84"x36"x8".
• 00817012031683 - K-4 D3X: 2025-06-16 Alternating Pressure, True Low Air Loss, AutoSet Technology, Pulsating, Auto Variable Length, Mattress System, 80"~85"~90"x 36"
• 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"