Panels › Gastroenterology, Urology › Product code PEV · Class 2
Dialysis Administration Kit
Regulation 876.5820
0510(k)s in 12 months (0 all time)
1recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in PEV
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 4 |
| Medical Action Industries, Inc. 306 | 0 | 1 |
| NxStage Medical, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2026 | Medical Action Industries, Inc. 306 Brand Name: Medical Action Industries
Product Name: Dialysis Change Tray Clear Sequence
Model/Catalog Number: 78791 Open, Classified |
PEV | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit Open, Classified |
PEV | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ;
2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH;
3) DIALYSIS PACK , Pack Number DYNJ36932A ;
4) DIA Open, Classified |
PEV | None listed |
| Aug 27, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure packs containing Shenli syringes, labeled as follows:
1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ;
2) DIALYSIS PACK , Pack Number DYNJ36932A ;
3) DIALYSIS AV SHUNT #668229 Open, Classified |
PEV | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Kits, trays, and packs labeled as follows:
DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088 Open, Classified |
PEV | None listed |
| Aug 27, 2019 | NxStage Medical, Inc. Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices:
1) NxStage One, Model NX1000-1;
2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A;
3) NxStage One, Model N Terminated |
PEV | K050525 |
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