The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Gi Bleeder/od Set.
| Device ID | K913476 |
| 510k Number | K913476 |
| Device Name: | GI BLEEDER/OD SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Araceli C Fancher |
| Correspondent | Araceli C Fancher ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-05 |
| Decision Date | 1992-02-12 |