| Primary Device ID | 28053326003732 |
| NIH Device Record Key | 6eb3ad7a-5684-47f1-b694-d6d26a6bb430 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LBM® UriSponge™ |
| Version Model Number | 8C021S01.A |
| Catalog Number | 8C021S01.A |
| Company DUNS | 428981112 |
| Company Name | COPAN ITALIA SPA |
| Device Count | 30 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08053326003738 [Unit of Use] |
| GS1 | 18053326003735 [Primary] |
| GS1 | 28053326003732 [Package] Contains: 18053326003735 Package: [10 Units] In Commercial Distribution |
| JSM | Culture Media, Non-Propagating Transport |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 28053326003749 | UriSponge™ – Urine Collection, Transport and Preservation System Mini size - in single pouc |
| 28053326003732 | UriSponge™ – Urine Collection, Transport and Preservation System Regular size - in single po |
| 28053326003725 | UriSponge™ – Urine Collection, Transport and Preservation System Mini size - in bulk |
| 28053326003718 | UriSponge™ – Urine Collection, Transport and Preservation System Regular size - in bulk |