The following data is part of a premarket notification filed by Omnicell, Inc. with the FDA for Ivx Fluid Transfer Set.
| Device ID | K212530 |
| 510k Number | K212530 |
| Device Name: | IVX Fluid Transfer Set |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | Omnicell, Inc. 500 Cranberry Woods Drive Cranberry, PA 16066 |
| Contact | David Vanella |
| Correspondent | David Vanella Omnicell, Inc. 500 Cranberry Woods Drive Cranberry, PA 16066 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-11 |
| Decision Date | 2022-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860007260404 | K212530 | 000 |
| 00860007260421 | K212530 | 000 |