| Primary Device ID | 00616784304212 |
| NIH Device Record Key | bf3383a5-1b24-4b08-b16b-6e66c68e2902 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DMECare Solutions Solid Seat Insert |
| Version Model Number | 13041-18 |
| Company DUNS | 008124539 |
| Company Name | Dynarex Corporation |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616784304212 [Primary] |
| GS1 | 00616784304243 [Package] Package: Shipper [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 | 3 |
| Public Version Date | 2025-07-17 |
| Device Publish Date | 2021-09-01 |
| 00616784304519 | Solid Seat Insert 24" x 18". Weight Capacity: 300 LB |
| 00616784304410 | Solid Seat Insert 22" x 18" Weight Capacity: 300 LB |
| 00616784304311 | Solid Seat Insert 20" x 16". Weight Capacity: 300 LB |
| 00616784304212 | Solid Seat Insert 18"x 16". Weight Capacity: 300 LB |
| 00616784304113 | Solid Seat Insert 16"x16". Weight Capacity: 300 LB. |