# GDS (Grifols Donation System) - 1.0 (BK180240)

_Biomat USA, Inc. · Nov 5, 2018 · SESE_

**Canonical URL:** https://fda.innolitics.com/device/BK180240

## Device Facts

- **Applicant:** Biomat USA, Inc.
- **Decision Date:** Nov 5, 2018
- **Decision:** SESE

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**Source:** [https://fda.innolitics.com/device/BK180240](https://fda.innolitics.com/device/BK180240)

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