KPO

Product Code: KPO


Products Classified as KPO

1975Dialysate Concentrate For Hemodialysis (liquid Or Powder)Hemodialysis System And Accessories.

Total Product Life Cycle (TPLC) Devices

1975Dialysate Concentrate For Hemodialysis (liquid Or Powder)Hemodialysis System And Accessories.

FDA Consensus Standards

Dialysate Concentrate For Hemodialysis (Liquid Or Powder) [36807]21 CFR §876.5820 🔎
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) [36809]21 CFR §876.5820 🔎
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) [36808]21 CFR §876.5820 🔎
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) [36806]21 CFR §876.5820 🔎

Pre-market Notifications for KPO

K212620Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC
K212052HMB32 Dialysis SolutionHaemopharm Biofluids S.r.l.
K202508Hemo-Lyte C CartridgeDi-Chem, Inc.
K193155Nipro Dry Complete Dry Acid Concentrate For HemodialysisNipro Renal Solutions USA, Corp.
K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC
K192017Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC
K191474NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)Fresenius Medical Care Renal Therapies Group, LLC
K191093Isopure Dry Acid Dissolution SystemIsopure, Corp.
K180679CitriCon Liquid And Powder (Acid Concentrate Acidified With Citric Acid), AcetiCon Liquid And Powder (Acid Concentrate Acidified With Acetic Acid Or Na Di Acetate), BicarboCon Liquid And Powder (Bicarb Concentrate), RenaCon Liquid And Powder (AcetateGlobal Scientific Technologies, LLC
K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC
K171015CitryteDi-Chem, Inc.
K162887PrismaSATEBaxter Healthcare Corporation
K162716BibagFRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
K160847Rockwell Medical CitraPure Acid ConcetrateROCKWELL MEDICAL
K150966HMB32HAEMOPHARM BIOFLUIDS SRL

Global Unique Device Identification Database

00814963021459Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
00814963021442Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
00814963021435Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
00814963021428Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
00814963021411Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
00814963021404Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
00814963021398Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
00814963021381Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
10814963021371Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
10814963021364Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
10814963021357Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
10814963021340Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
10814963021333Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
00814963021329Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
00814963021312Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Maude Adverse Events

NXSTAGE PUREFLOW B SOLUTIONNXSTAGE MEDICAL, INC.2020-03-24
DRY ACID 132 GALLON UNIT, ASSY TO SHIPCONCORD MANUFACTURING2020-03-04
PRISMASATEBAXTER HEALTHERCARE CORPORATION2020-02-28
COLLECTIVE CONCENTRATE- GRANUFLOCORPORATE2020-02-10
COLLECTIVE CONCENTRATE- GRANUFLOCORPORATE2020-02-10
COLLECTIVE CONCENTRATE- GRANUFLOCORPORATE2020-02-10
COLLECTIVE CONCENTRATE- GRANUFLOCORPORATE2020-02-10
COLLECTIVE CONCENTRATE- GRANUFLOCORPORATE2020-02-10
NXSTAGENXSTAGE MEDICAL, INC.2020-02-03
NXSTAGE SOLUTION 2KNXSTAGE MEDICAL, INC.2020-01-23
NXSTAGE SOLUTION 4KNXSTAGE MEDICAL, INC.2020-01-23
NXSTAGE PUREFLOW B SOLUTION 5000MLNXSTAGE MEDICAL, INC.2020-01-23
2008T GEN 2 BIBAG WITHOUT CDXCONCORD MANUFACTURING2020-01-14
COLLECTIVE CONCENTRATE- GRANUFLOCORPORATE2020-01-08
COLLECTIVE CONCENTRATE- GRANUFLOCORPORATE2020-01-07
DRY ACID 132 GALLON UNIT, ASSY TO SHIPCONCORD MANUFACTURING2019-11-27
NXSTAGE PUREFLOW B SOLUTIONNXSTAGE MEDICAL, INC.2019-11-19
COLLECTIVE CONCENTRATE- GRANUFLOOREGON MANUFACTURING PLANT2019-11-13
DRY ACID 99 GALLON UNIT, ASSY TO SHIPCONCORD MANUFACTURING2019-11-11
DRY ACID 99 GALLON UNIT, ASSY TO SHIPCONCORD MANUFACTURING2019-11-04
2008T GEN 2 BIBAG WITHOUT CDXCONCORD MANUFACTURING2019-10-28
2008T GEN 2 BIBAG WITHOUT CDXCONCORD MANUFACTURING2019-10-21
2008T GEN 2 BIBAG WITHOUT CDXCONCORD MANUFACTURING2019-10-21
DRY ACID 132 GALLON UNIT, ASSY TO SHIPCONCORD MANUFACTURING2019-10-01
DRY ACID 132 GALLON UNIT, ASSY TO SHIPCONCORD MANUFACTURING2019-09-26
2008T GEN 2 BIBAG WITHOUT CDXCONCORD MANUFACTURING2019-09-06
DRY ACID 132 GALLON UNIT, ASSY TO SHIPCONCORD MANUFACTURING2019-09-04
DRY ACID 132 GALLON UNIT, ASSY TO SHIPCONCORD MANUFACTURING2019-08-26
DRY ACID 132 GALLON UNIT, ASSY TO SHIPCONCORD MANUFACTURING2019-08-05
DRY ACID 132 GALLON UNIT, ASSY TO SHIPCONCORD MANUFACTURING2019-07-26
GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALOREGON MANUFACTURING PLANT2019-07-19
NATURALYTE DRY PACK RX-12OREGON MANUFACTURING PLANT2019-07-19
GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALOREGON MANUFACTURING PLANT2019-07-19
NATURALYTE DRY PACK RX-12OREGON MANUFACTURING PLANT2019-07-19
GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALOREGON MANUFACTURING PLANT2019-07-19
NATURALYTE DRY PACK RX-12OREGON MANUFACTURING PLANT2019-07-19
NATURALYTE DRY PACK RX-12OREGON MANUFACTURING PLANT2019-07-19
GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALOREGON MANUFACTURING PLANT2019-07-19
NATURALYTE DRY PACK RX-12OREGON MANUFACTURING PLANT2019-07-19
GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALOREGON MANUFACTURING PLANT2019-07-19
NATURALYTE DRY PACK RX-12OREGON MANUFACTURING PLANT2019-07-18
GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALOREGON MANUFACTURING PLANT2019-07-18
GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALOREGON MANUFACTURING PLANT2019-07-18
NATURALYTE DRY PACK RX-12OREGON MANUFACTURING PLANT2019-07-18
NATURALYTE DRY PACK RX-12OREGON MANUFACTURING PLANT2019-07-18
GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALOREGON MANUFACTURING PLANT2019-07-18
GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALOREGON MANUFACTURING PLANT2019-07-18
NATURALYTE DRY PACK RX-12OREGON MANUFACTURING PLANT2019-07-18
NATURALYTE DRY PACK RX-12OREGON MANUFACTURING PLANT2019-07-18
GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALOREGON MANUFACTURING PLANT2019-07-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.