| Primary Device ID | 00817012031140 |
| NIH Device Record Key | 83961b43-4ea2-44f2-90c9-00da864abeac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-3 AIRE ZONE |
| Version Model Number | K-3-W2.0-BB-MS-84-8 |
| Catalog Number | K-3-W2.0-BB-MS-84-8 |
| 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 |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com | |
| Phone | 951-340-4360 |
| sales@kapmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817012031140 [Primary] |
| IOQ | Bed, Flotation Therapy, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-27 |
| Device Publish Date | 2023-03-17 |
| 00817012031775 - K-6oem AIRE-TURN ASSIST | 2025-10-06 Rotation, On-Demand Low Air Loss, Variable length and Width Expansion / Extension, Mattress System 36"~42"~48"x 80"~85"~90"x 8", |
| 00817012031782 - K-6oem AIRE-TURN ASSIST | 2025-10-06 Rotation, On-Demand Low Air Loss, Variable length and Width Expansion / Extension, Mattress System 36"~42"~48"x 80"~85"~90"x 8", |
| 00817012031799 - K-6oem AIRE-TURN ASSIST | 2025-10-06 Rotation, On-Demand Low Air Loss, Variable length and Width Expansion / Extension, Mattress System 36"~42"~48"x 80"~85"~90"x 8", |
| 00817012031744 - K-2oem ALT-AIRE+ | 2025-09-29 Alternating Pressure, On-Demand Low Air Loss, Expansion/Extension, Expandable Mattress System, 80"~85"~90"x 36" ~42"~48"x 8". |
| 00817012031751 - K-2oem ALT-AIRE+ | 2025-09-29 Alternating Pressure, On-Demand Low Air Loss, Expansion/Extension, Expandable Mattress System, 80"~85"~90"x 36" ~42"~48"x 8" wit |
| 00817012031768 - K-2oem ALT-AIRE+ | 2025-09-29 Alternating Pressure, On-Demand Low Air Loss, Expansion/Extension, Expandable Mattress System, 80"~85"~90"x 36" ~42"~48"x 8" wit |
| 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". |