The following data is part of a premarket notification filed by Nurse Assist, Inc. with the FDA for Normal Saline Flush.
| Device ID | K150143 |
| 510k Number | K150143 |
| Device Name: | Normal Saline Flush |
| Classification | Saline, Vascular Access Flush |
| Applicant | NURSE ASSIST, INC. 4409 Haltom Rd Haltom City, TX 76117 |
| Contact | Brian Cox |
| Correspondent | Brian Cox NURSE ASSIST, INC. 4409 Haltom Rd Haltom City, TX 76117 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-22 |
| Decision Date | 2015-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B15088815731254 | K150143 | 000 |
| B15012032 | K150143 | 000 |
| B15012034 | K150143 | 000 |
| B1501203BP2 | K150143 | 000 |
| B1501203BP4 | K150143 | 000 |
| B15012052 | K150143 | 000 |
| B15012054 | K150143 | 000 |
| B1501205BP2 | K150143 | 000 |
| B1501205BP4 | K150143 | 000 |
| B15012102 | K150143 | 000 |
| B15012104 | K150143 | 000 |
| B1501210BP2 | K150143 | 000 |
| B1501210BP4 | K150143 | 000 |
| B15088815731212 | K150143 | 000 |
| B15088815731214 | K150143 | 000 |
| B15088815731232 | K150143 | 000 |
| B15088815731234 | K150143 | 000 |
| B15088815731252 | K150143 | 000 |
| 30885632389751 | K150143 | 000 |