| Primary Device ID | 08033928530146 |
| NIH Device Record Key | 7d879e16-68af-4cd2-a4f0-d5460469b7d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemoWeld Gun Handgun |
| Version Model Number | HWG2.01 |
| Company DUNS | 440621212 |
| Company Name | DELCON SRL |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 08033928530146 [Primary] |
| KSD | Device, Heat-Sealing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 08033928530498 - ROMA Cordless handheld sealer for blood bag tubing | 2023-08-02 ROMA Cordless handheld sealer for blood bag tubing |
| 08033928530795 - ROMA Charger | 2023-08-02 ROMA Charger |
| 08033928530818 - HemoWeld-Gun | 2023-08-02 HemoWeld-Gun Portable sealer for blood bag tubes |
| 08033928530016 - HemoMix 3 | 2022-12-15 HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag wi |
| 08033928530023 - HemoMix 3 | 2022-12-15 HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag wi |
| 08033928530115 - HemoWeld-T | 2022-12-15 Bench tube sealer for medical PVC tubes |
| 08033928530122 - HemoWeld-Gun | 2022-12-15 HemoWeld-Gun Portable sealer for blood bag tubes - Holder Kit |
| 08033928530139 - HemoWeld-Gun | 2022-12-15 Portable sealer for blood bag tubes - Case Kit |