| Primary Device ID | 50618029980064 |
| NIH Device Record Key | c5d7bc35-745c-49ef-aeab-6b96d60b0ddf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Streamline External Urine Management device |
| Version Model Number | 700-120 |
| Catalog Number | 700-120 SMS |
| Company DUNS | 054326178 |
| Company Name | SAGE PRODUCTS, LLC |
| 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 | true |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00618029980069 [Primary] |
| GS1 | 50618029980064 [Package] Contains: 00618029980069 Package: case [40 Units] In Commercial Distribution |
| NZU | Collector, urine, powered, non indwelling catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-01 |
| Device Publish Date | 2022-05-24 |
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