| Primary Device ID | 00616784422824 |
| NIH Device Record Key | a532e725-5ceb-4ab8-b7ec-51dac9bea6ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sitz Bath |
| Version Model Number | 4228 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| Device Count | 10 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00616784422824 [Unit of Use] |
| GS1 | 00616784422831 [Primary] |
| KTC | Bath, Sitz, Nonpowered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-09 |
| Device Publish Date | 2021-09-01 |
| 00616784345512 - Durma+ Unna Boot Bandage with Zinc Oxide and Calamine | 2025-12-26 Size: 3" x 10 yd. (7.6 cm x 9.1m) |
| 00616784345611 - Durma+ Unna Boot Bandage with Zinc Oxide and Calamine | 2025-12-26 Size: 4" x 10 yd. (10.2 cm x 9.1m) |
| 00616784345314 - Durma+ Unna Boot Bandage with Zinc Oxide | 2025-12-25 3" x 10" yd (7.6 cm x 9.1 m) |
| 00616784345437 - Durma+ Unna Boot Bandage with Zinc Oxide | 2025-12-25 4" x 10 yd (10.2 cm x 9.1m) |
| 00840117345751 - Durma+ SiliGentle Silicone Foam Dressing, Bordered | 2025-12-18 4" x 8" (10,cm x 20,3 cm) , STERILE-EO |
| 00840117345782 - Durma+ SiliGentle Silicone Foam Dressing, Bordered | 2025-12-18 8" x 8" (20,3 cm x 20,3 cm), STERILE-EO |
| 00840117345812 - Durma+ SiliGentle Silicone Foam Dressing, Bordered | 2025-12-18 8" x 6" (20,3 cm x 15,2 cm), STERILE-EO |
| 00840117345539 - Durma+ Y-Type Suction Drainage Tube, 10 Fr | 2025-12-02 |