Primary Device ID | 08033928530443 |
NIH Device Record Key | c6362b83-a10f-4eba-a7ea-1757343fce3e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | WELD B |
Version Model Number | HWELD-B.DB.00G |
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 | 08033928530443 [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 |
08033928530825 - MILANO | 2024-11-04 HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag wi |
08033928530832 - MILANO | 2024-11-04 HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag wi |
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 |