| Primary Device ID | 58053326001920 |
| NIH Device Record Key | 8f1844eb-2068-4bc8-a664-aeed2256b6f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BBL™ CultureSwab™ Plus |
| Version Model Number | 220125 |
| Catalog Number | 220125 |
| Company DUNS | 428981112 |
| Company Name | COPAN ITALIA SPA |
| Device Count | 50 |
| 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 | 18053326001922 [Unit of Use] |
| GS1 | 38053326001926 [Primary] |
| GS1 | 58053326001920 [Package] Contains: 38053326001926 Package: [10 Units] In Commercial Distribution |
| JSL | Culture Media, Anaerobic 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 |
| 58053326001920 | CultureSwab Plus Amies Charcoal Flexible |
| 58053326001906 | CultureSwab Plus Amies Charcoal |
| 58053326001890 | CultureSwab Plus Amies Charcoal Single |
| 58053326001869 | CultureSwab Plus Amies Charcoal Double |
| 58053326001852 | CultureSwab Plus Amies w/o Charcoal Double |
| 58053326001845 | CultureSwab Plus Amies w/o Charcoal Minitip |
| 58053326001838 | CultureSwab Plus Amies w/o Charcoal Soft |
| 58053326001821 | CultureSwab Plus Amies w/o Charcoal |
| 58053326001609 | CultureSwab Plus Amies w/o Charcoal Single |