| 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 |
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