| Primary Device ID | 35060120951961 |
| NIH Device Record Key | 0168932d-0285-4692-b6e7-df9554eaab51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neo-natal HMEF |
| Version Model Number | 9080/100BAUA001/0001 |
| Company DUNS | 769934225 |
| Company Name | GVS FILTER TECHNOLOGY UK LTD |
| 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 | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15060120951967 [Primary] |
| GS1 | 25060120951964 [Package] Contains: 15060120951967 Package: Inner box [50 Units] In Commercial Distribution |
| GS1 | 35060120951961 [Package] Contains: 25060120951964 Package: Outer box [300 Units] In Commercial Distribution |
| CAH | Filter, Bacterial, Breathing-Circuit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| 15060120959710 - Smoke Set | 2024-08-09 The combination particle and gas filter is used as part of a smoke evacuation system which reduces particulate and odour causing |
| 15060120959772 - Smoke Gas Evacuation Tube Set | 2024-08-09 The combination particle and gas filter is used as part of a smoke evacuation system which reduces particulate and odour causing |
| 15060120959727 - Insufflation Set | 2024-08-08 To be used in conjunction with insufflators for intra-abdominal insufflation. Single use, disposable device. |
| 15060120957747 - HEPA Ventilation Filter | 2020-07-06 |
| 25060120956297 - Multi-Vent | 2018-12-31 |
| 35060120950100 - ECO HMEF | 2018-07-06 |
| 35060120950773 - ECO Maxi Filter | 2018-07-06 |
| 35060120951671 - Spiroguard | 2018-07-06 |