| Primary Device ID | 05411967003471 |
| NIH Device Record Key | e76f535c-18e9-469b-93b8-1b19a1401b93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InActiv Blue |
| Version Model Number | IB_TUB |
| Company DUNS | 373904101 |
| Company Name | Fertipro NV |
| Device Count | 1 |
| 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 |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05411967003464 [Primary] |
| GS1 | 05411967003471 [Package] Contains: 05411967003464 Package: Rack [50 Units] In Commercial Distribution |
| GS1 | 05411967003488 [Package] Contains: 05411967003464 Package: Carboard box [1200 Units] In Commercial Distribution |
| GS1 | 05411967003778 [Package] Contains: 05411967003464 Package: Carboard box [400 Units] In Commercial Distribution |
| QBD | Microbial Nucleic Acid Storage And Stabilization Device |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-22 |
| Device Publish Date | 2024-08-14 |
| 05411967003471 - InActiv Blue | 2024-08-22InActiv Blue is a pathogen-inactivating and DNA/RNA stabilizing medium used for transport of naso- or oropharyngeal swabs, or saliva sampled from patients for in vitro diagnostic testing on the presence of genetic material of a virus by RT-qPCR or other molecular method (SARS-CoV-2, Influenza A/B, RSV A/B). |
| 05411967003471 - InActiv Blue | 2024-08-22 InActiv Blue is a pathogen-inactivating and DNA/RNA stabilizing medium used for transport of naso- or oropharyngeal swabs, or sa |
| 05411967000050 - HOS Test | 2023-04-28 Sperm vitality test The hypo-osmotic swelling test is a sperm vitality test based on the principle that live spermatozoa swell d |
| 05411967001231 - FertiCult High Viscosity Oil | 2023-03-08 FertiCult High Viscosity Oil - HVOIL050P (50ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral oi |
| 05411967001248 - FertiCult High Viscosity Oil | 2023-03-08 FertiCult High Viscosity Oil - HVOIL100P (100ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral o |
| 05411967001255 - FertiCult High Viscosity Oil | 2023-03-08 FertiCult High Viscosity Oil - HVOIL500P (500ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral o |
| 05411967001187 - FertiCult High Viscosity Oil | 2023-03-08 FertiCult High Viscosity Oil - HVOIL050 (50ml in glass bottle) is pre-washed with water, ready to use, high viscosity mineral oi |
| 05411967001200 - FertiCult High Viscosity Oil | 2023-03-08 FertiCult High Viscosity Oil - HVOIL100 (100ml in glass bottle) is pre-washed with water, ready to use, high viscosity mineral o |
| 05411967001224 - FertiCult High Viscosity Oil | 2023-03-08 FertiCult High Viscosity Oil - HVOIL500 (500ml in glass bottle) is pre-washed with water, ready to use, high viscosity mineral o |