| Primary Device ID | 30014613337416 |
| NIH Device Record Key | 4b7b73f2-95cc-4895-8b66-e7d8a409214d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DHI Specimen Collection System |
| Version Model Number | 99-08021 |
| Catalog Number | 99-08021 |
| Company DUNS | 117359612 |
| Company Name | DIAGNOSTIC HYBRIDS, INC. |
| 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 | 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 | 30014613337416 [Primary] |
| KXG | APPLICATOR, ABSORBENT TIPPED, STERILE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2019-12-03 |
| 30014613337362 | UTM with Ultra Minitip FLOQSwab set |
| 30014613337355 | UTM with Ultra Minitip FLOQSwab set - 1mL |
| 30014613337317 | UTM with Flexible minitip FLOQSwab Set |
| 30014613337300 | UTM with Regular FLOQSwab Set - 1mL |
| 30014613337294 | UTM with Minitip FLOQSwab Set - 1mL |
| 30014613337263 | UTM with Nasopharyngeal FLOQSwab Set |
| 30014613337249 | UTM with Regular FLOQSwab Set |
| 30014613337225 | UTM with Minitip FLOQSwab Set |
| 30014613335450 | 3.0-ML UTM W/ FLEX NASOPHAR |
| 30014613335443 | KIT, MALE WITH UTM |
| 30014613335436 | KIT, FEMALE WITH UTM |
| 30014613331674 | PED COUNT 50MM AND 1ML UTM |
| 30014613331650 | PED CONT 80MM AND 3ML UTM |
| 30014613331643 | UTM with Adult Contoured FLOQSwab set |
| 30014613337430 | UTM with Mattress Swab Set |
| 30014613337423 | UTM with Flocked Swabs (Regular) |
| 30014613337416 | UTM with Flocked Swabs(1 flexible minitip, 1 regular) |
| 30014613337409 | UTM with Flexible Minitip Flocked Swab |
| 30014613337393 | UTM with Flexible Minitip Flocked Swab |
| 30014613337386 | UTM with Regular Flocked Swab |
| 30014613337201 | VCM with Nasopharyngeal Flocked swab |
| 30014613337195 | VCM with Urethral Flocked Swab |
| 30014613337188 | VCM with Lesion Swab |
| 30014613337171 | VCM with Cervical Swab |
| 30014613338055 | U. Minitip & Std Flock w/ 1mL |
| 30014613339311 | OP Swab with Transport Tube |
| 30014613339236 | NP Swab with Transport Tube |