| Primary Device ID | 00817012022261 |
| NIH Device Record Key | 6c314c9d-6b41-4ae7-8bd4-4729bb28a44b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-Z EZ-TURN |
| Version Model Number | K-ZB42X84 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817012022261 [Primary] |
| IKZ | Bed, Patient Rotation, 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 | 2019-03-27 |
| Device Publish Date | 2019-03-19 |
| 00817012021776 | Lateral Rotation with True Low Air Loss Bariatric Mattress System, 80" x 48" x 10" |
| 00817012023701 | K-Z Alternating Rotation, True Low Air Loss, Expandable Mattress System, 80" ~84"~88" x 36"~39/4 |
| 00817012022261 | Lateral Rotation with True Low Air Loss Mattress System, 84" x 42" x 10" |
| 00817012031638 | Lateral Turning, True Low Air Loss, Mattress System, 40"x48"x10", 220V AC, with UK Power Cord |