The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Plum 360 Infusion System With Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module For Plum A+ Infusion System Upgrade.
| Device ID | K141789 |
| 510k Number | K141789 |
| Device Name: | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE |
| Classification | Pump, Infusion |
| Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
| Contact | Yuliya Matlin |
| Correspondent | Yuliya Matlin HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
| Product Code | FRN |
| Subsequent Product Code | FPA |
| Subsequent Product Code | PHC |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2015-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20887787009228 | K141789 | 000 |
| 30887709100122 | K141789 | 000 |
| M3353001004081 | K141789 | 000 |
| M3353001004071 | K141789 | 000 |
| M3353001004061 | K141789 | 000 |
| 10887709102047 | K141789 | 000 |
| 10887709102030 | K141789 | 000 |
| 10887709102023 | K141789 | 000 |
| 10887709102474 | K141789 | 000 |
| 10887709102467 | K141789 | 000 |
| 10887709102450 | K141789 | 000 |
| 10887709102481 | K141789 | 000 |
| 20887709101832 | K141789 | 000 |
| 20887709101849 | K141789 | 000 |
| 10887709102054 | K141789 | 000 |
| 20887787009211 | K141789 | 000 |
| 20887787008801 | K141789 | 000 |
| 20887787008795 | K141789 | 000 |
| 20887787008771 | K141789 | 000 |
| 20887787008764 | K141789 | 000 |
| 20887787008566 | K141789 | 000 |
| 20887787005725 | K141789 | 000 |
| 20887787005398 | K141789 | 000 |
| 20887787003431 | K141789 | 000 |
| 20887787003233 | K141789 | 000 |
| 20887787003202 | K141789 | 000 |
| 20887787003226 | K141789 | 000 |