| Primary Device ID | 00369771001518 |
| NIH Device Record Key | fd768e65-f0ea-4ed3-94ec-01f5478a9769 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HMEF w/ Flextube |
| Version Model Number | 19-HMEF100 |
| Company DUNS | 361663839 |
| Company Name | GERI-GENTLE CORPORATION |
| Device Count | 30 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00369771001518 [Unit of Use] |
| GS1 | 00369771001525 [Primary] |
| CAH | Filter, Bacterial, Breathing-Circuit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-12-22 |
| Device Publish Date | 2020-06-01 |
| 00369771003659 - Sharps Collector 5QT | 2023-11-09 Sharps Collector 5QT |
| 00369771003390 - Pen Needle | 2023-09-11 Safety Pen Needle 30G |
| 00369771003437 - Prefilled Syrings | 2023-09-11 10ML PREFILLED SYRINGE |
| 00369771003161 - Oxygen Concentrator | 2023-08-09 Oxygen Concentrator |
| 20369771000782 - Lancets Safety | 2023-08-09 Lancets Safety |
| 00369771003123 - SYRINGE RETRACT U100 1cc 29x.5 | 2023-07-10 SYRINGE RETRACT U100 1cc 29x.5 |
| 20369771000898 - Syringes Safety | 2023-02-22 SYR U100 1cc 29x.5 |
| 20369771000904 - Syringes Safety | 2023-02-22 SYR U100 .5cc 29x.5 |