| Primary Device ID | 00810050852678 |
| NIH Device Record Key | 1f0e82e4-3c60-4e7b-9f3f-9c7637c0d3db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Specimen Collection Swab |
| Version Model Number | SW0103XSP |
| Company DUNS | 600850213 |
| Company Name | TYPENEX MEDICAL 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810050852654 [Primary] |
| GS1 | 00810050852678 [Package] Contains: 00810050852654 Package: Case [100 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 | 2022-11-21 |
| Device Publish Date | 2022-11-11 |
| 00810050852173 | Specimen Collection Swab - Oropharyngeal |
| 00810050852135 | Specimen Collection Swab - Nasopharyngeal |
| 00810050851930 | Specimen Collection Swab - Oropharyngeal |
| 00810050851916 | Specimen Collection Swab - Nasopharyngeal |
| 00810050851862 | Specimen Collection Swab - Oropharyngeal |
| 00810049689988 | Specimen Collection Swab - Nasopharyngeal |
| 00810050852685 | Oropharyngeal Swab - Spanish |
| 00810050852678 | Nasopharyngeal Swab - Spanish |
| 00810050852647 | Oropharyngeal Swab - Spanish |
| 00810050852623 | Nasopharyngeal Swab |
| 00810050852609 | 3" Polyester Swab |
| 00810050852180 | Oropharyngeal Swab |