| Primary Device ID | 00860004936879 |
| NIH Device Record Key | ebe0487e-fc37-4cf3-b608-7620c4c3e2cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EasyBoost SPU Zipper Sheet with Side Handles |
| Version Model Number | ESB-DIS-2027 |
| Company DUNS | 117658378 |
| Company Name | Seneca Devices, Inc. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004936879 [Primary] |
| GS1 | 10860004936876 [Package] Package: Case [12 Units] In Commercial Distribution |
| FMR | Device, Transfer, Patient, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-25 |
| Device Publish Date | 2024-10-17 |
| 00860004936824 - EasyBoost 400 | 2024-10-25 Air blower unit (with hook) for use with EasyBoost Cushion, for safe working load up to 400 lbs |
| 00860004936879 - EasyBoost SPU Zipper Sheet with Side Handles | 2024-10-25Case of 12 Sheets with zipper and side handles for in-bed repositioning, Polyester fabric, 66" x 108" |
| 00860004936879 - EasyBoost SPU Zipper Sheet with Side Handles | 2024-10-25 Case of 12 Sheets with zipper and side handles for in-bed repositioning, Polyester fabric, 66" x 108" |
| 00860004936831 - EasyBoost | 2024-08-08 EasyBoost repositioning system compatible with HoverMatt. |
| 00860004936855 - EasyBoost | 2024-07-17 EasyBoost Repositioning System V1 Compatible with EasyShift Zipper Sheet |
| 00860004936817 - EasyShift | 2024-01-22 EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet |
| 00860004936848 - EasyShift | 2024-01-22 EasyShift Repositioning System V3 for 36-inch wide mattress |
| 10860004936869 - EasyShift Sheet | 2024-01-22 EasyShift SPU Zipper Sheet |