| Primary Device ID | 35020583700704 |
| NIH Device Record Key | a8cb15bf-eddd-4178-806c-2f0cb24b7c74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Platelet Additive Solution Connection Adapter |
| Version Model Number | 70070 |
| Catalog Number | 70070 |
| Company DUNS | 801679200 |
| Company Name | TERUMO BCT, INC. |
| 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 | true |
| 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 |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | 1 877-339-4228 |
| FDAUDIprogram@terumobct.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 35020583700704 [Primary] |
| GKT | Separator, Automated, Blood Cell, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-15 |
| Device Publish Date | 2021-06-07 |
| 35020583700704 | PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER |
| 05020583700703 | PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER |