| Primary Device ID | M68980875080 |
| NIH Device Record Key | 6108ade7-d212-4b9b-aef4-b9972d2d2042 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Low Titer Type O FWB Transfusion Set |
| Version Model Number | 08 |
| Catalog Number | 80-875 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, LLC |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M68980875080 [Primary] |
| BRZ | Set, Blood Transfusion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-31 |
| Device Publish Date | 2022-08-23 |
| M69880875020 | LOW TITER TYPE O FWB TRANSFUSION SET Constricting Band (18"x1") 1 ea Safety IV Catheter 16gx1.2 |
| M68980875010 | LOW TITER TYPE O FWB TRANSFUSION SET Constricting Band (18"x1") 1 ea Safety IV Catheter 16gx1.2 |
| M68980875080 | LOW TITER TYPE O FWB TRANSFUSION SET Constricting Band 1 ea Safety IV |
| M68980875090 | LOW TITER TYPE O FWB TRANSFUSION SET Constricting Band 1 ea Safety IV |