NU-SITE
Set, Administration, Intravascular
MEDEX, INC.
The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Nu-site.
Pre-market Notification Details
| Device ID | K943897 |
| 510k Number | K943897 |
| Device Name: | NU-SITE |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-10 |
| Decision Date | 1995-02-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688500685 | K943897 | 000 |
| 50351688505413 | K943897 | 000 |
| 50351688500654 | K943897 | 000 |
| 50351688500647 | K943897 | 000 |
| 50351688500555 | K943897 | 000 |
| 50351688500487 | K943897 | 000 |
Trademark Results [NU-SITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NU-SITE 74407742 1928534 Live/Registered |
SMITHS MEDICAL ASD, INC. 1993-06-28 |
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