The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for U-mid Prefilled Humidifier (300cc).
| Device ID | K760587 |
| 510k Number | K760587 |
| Device Name: | U-MID PREFILLED HUMIDIFIER (300CC) |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-03 |
| Decision Date | 1976-10-15 |