| Primary Device ID | 00616784471136 |
| NIH Device Record Key | 451a0934-12d5-45ff-8fc9-f7b75b7b29cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cleansing Enema Set |
| Version Model Number | 4711 |
| 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 | 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 | 00616784471129 [Primary] |
| GS1 | 00616784471136 [Package] Contains: 00616784471129 Package: Case [50 Units] In Commercial Distribution |
| FCE | Enema Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-29 |
| Device Publish Date | 2021-06-21 |
| 00810180840712 - CurPro Dermal Curettes,2 mm | 2026-03-27 Sterile-R |
| 00840117347892 - Medi-Cut Safety Scalpel | 2026-03-27 Medi-Cut Safety Scalpel, Sterile, # 15 |
| 00810180844901 - Disposable Prep Razors | 2026-03-25 Disposable Prep Razors |
| 00810180844918 - Medicine Cups 1oz | 2026-03-25 |
| 00810180844925 - LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal | 2026-03-25 Sterile-EO |
| 00810180844703 - Bandage Shears 7.5" Orange | 2026-03-24 |
| 00810180844710 - Bandage Shears 7.5" Purple | 2026-03-24 |
| 00810180844840 - Emesis Basin | 2026-03-24 Emesis Basin, 9", Graduated in 100cc, Mauve |