Pentair
39 catalogue numbers from 345280000, listed by Pentair Filtration Solutions, United States, under Filter, Prebypass, Cardiopulmonary Bypass. 1 manufacturer in China is registered for this product code.
1manufacturer
39catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
Record
| Listed by | Pentair Filtration Solutions, United States |
|---|---|
| FDA product code | KRJ |
| Device type | Filter, Prebypass, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4280 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K990276 |
| Record published | 2017-12-31 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 50 to 90 °F; Handling environment temperature 50 to 90 °F |
| Distribution end date | 2026-01-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 345280000 | 75 | In distribution | |
| 345260000 | 75 | In distribution | |
| 030218 | 75 | In distribution | |
| DPB3022 | 75 | In distribution | |
| 0008002022 | 100 | In distribution | |
| 17016902 | 75 | In distribution | |
| 000803812 | 75 | In distribution | |
| DPC2023S500C | 100 | In distribution | |
| 1021039 | 75 | In distribution | |
| 000801212 | 75 | In distribution | |
| 701031084 | 75 | In distribution | |
| DPB3033PES002YV | 75 | In distribution | |
| 701021039 | 75 | In distribution | |
| 0008002033 | 100 | In distribution | |
| DPB3022PES002YN | 75 | In distribution | |
| 6125 | 100 | In distribution | |
| 0008002023 | 100 | In distribution | |
| 472423000001 | 75 | In distribution | |
| 415000220 | 100 | In distribution | |
| 6126 | 100 | In distribution | |
| 701054385 | 100 | In distribution | |
| DPB3032PES002YV | 75 | In distribution | |
| 345290000 | 100 | In distribution | |
| 1031084 | 75 | In distribution | |
| 000881089 | 75 | In distribution | |
| 1031086 | 75 | In distribution | |
| 0008002012 | 100 | In distribution | |
| 0008002011 | 100 | In distribution | |
| 000803838 | 75 | In distribution | |
| 701031086 | 75 | In distribution | |
| 415000221 | 100 | In distribution | |
| DPB3033PES002YN | 75 | In distribution | |
| 1021040 | 75 | In distribution | |
| 017016901 | 75 | In distribution | |
| DPB3032PES002YN | 75 | In distribution | |
| 345270000 | 75 | In distribution | |
| 701021040 | 75 | In distribution | |
| 017016900 | 75 | In distribution | |
| DPC2022S500C | 100 | Withdrawn |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.