| Primary Device ID | 58053326002156 |
| NIH Device Record Key | 3ddf1bee-ed5a-4dfc-925f-2b56ce53ed6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BBL™ CultureSwab™ EZ II |
| Version Model Number | 220145 |
| Catalog Number | 220145 |
| Company DUNS | 428981112 |
| Company Name | COPAN ITALIA SPA |
| Device Count | 100 |
| 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 | 18053326002158 [Unit of Use] |
| GS1 | 38053326002152 [Primary] |
| GS1 | 58053326002156 [Package] Contains: 38053326002152 Package: [6 Units] In Commercial Distribution |
| JTW | System, Transport, Aerobic |
| 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 |
| 58053326011509 - FLOQSwabs® | 2024-07-10 Specimen collection swab, regular, breaking point 60mm, in tube |
| 58053326011523 - FLOQSwabs® | 2024-07-10 Specimen collection swab, regular, 60 mm breakpoint, in tube |
| 28053326004524 - Sample Diluent Tube | 2024-05-15 1ML SAMPLE DILUENT TUBE IN BULK |
| 38053326002206 - FecalSwab® | 2024-05-15 2 ml modified Cary Blair Orange Cap+Flocked Swab |
| 58053326005591 - CLASSIQSwabs™ | 2024-05-07 Sterile Plastic Applicator Poliester Tipped Individually Wrapped |
| 58053326005690 - CLASSIQSwabs™ | 2024-05-07 Sterile Plastic Applicator Rayon Tipped Individually Wrapped |
| 58053326009797 - CLASSIQSwabs™ | 2024-05-07 Regular Polyester Swab, breaking point 100mm |
| 18053326009577 - FLOQSwabs ® | 2024-03-06 Regular, Sterile Single Wrapped, Molded bp |