| Primary Device ID | 80092237604324 |
| NIH Device Record Key | 2c525daa-1421-4bd1-9221-ddf6bd8190e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wheelchair Back Cushion Foam - 20 x 19 |
| Version Model Number | BKF-2019 |
| Company DUNS | 022542271 |
| Company Name | Roscoe 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 | 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00092237604328 [Primary] |
| GS1 | 80092237604324 [Package] Contains: 00092237604328 Package: Carton [10 Units] In Commercial Distribution |
| IMP | Cushion, Wheelchair |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-12-01 |
| Device Publish Date | 2020-11-11 |
| 00092237604212 - Wheelchair Foam Cushion - 22 x 16 x 3 | 2020-12-01 |
| 80092237604225 - Wheelchair Foam Cushion - 22 x 18 x 3 | 2020-12-01 |
| 80092237604232 - Wheelchair Foam Cushion - 24 x 18 x 3 | 2020-12-01 |
| 80092237604300 - Wheelchair Back Cushion Foam - 16 x 17 | 2020-12-01 |
| 80092237604317 - Wheelchair Back Cushion Foam - 18 x 17 | 2020-12-01 |
| 80092237604324 - Wheelchair Back Cushion Foam - 20 x 19 | 2020-12-01 |
| 80092237604324 - Wheelchair Back Cushion Foam - 20 x 19 | 2020-12-01 |
| 80092237604331 - Wheelchair Back Cushion Foam - 22 x 19 | 2020-12-01 |
| 80092237604270 - Coccyx Cushion Memory Foam - 18 x 16 x 3 | 2020-12-01 |