| Primary Device ID | 58053326006796 |
| NIH Device Record Key | 976c538f-ae71-4762-8bcd-4f63cfeaee57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLOQSwabs® hDNA Free |
| Version Model Number | 50U009DS02 |
| Catalog Number | 50U009DS02 |
| Company DUNS | 428981112 |
| Company Name | COPAN ITALIA SPA |
| Device Count | 100 |
| 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 | 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 | 18053326006798 [Unit of Use] |
| GS1 | 38053326006792 [Primary] |
| GS1 | 58053326006796 [Package] Contains: 38053326006792 Package: [10 Units] In Commercial Distribution |
| KXG | Applicator, Absorbent Tipped, Sterile |
| 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 |
| 58053326006796 | Regular, Sterile, 2pcs Packed |
| 58053326006789 | Regular, Sterile Single Wrapped |
| 58053326006772 | Regular Molded bp 20mm, Sterile, 2pcs Packed |
| 58053326006765 | Regular sterile in dry tube Molded Break Point 20 mm |
| 58053326006741 | Regular, Sterile Single Wrapped, Molded bp 20mm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLOQSWABS 79096486 4137402 Live/Registered |
COPAN ITALIA S.P.A. 2011-02-09 |