Set, Administration, For Peritoneal Dialysis, Disposable
FDA product code KDJ · 111 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.5630
- Review panel
- GU
- Implant
- No
- Life sustaining
- Yes
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1977-12-20 – 2025-04-03
KDJ
2025-04-03
KDJ
2024-03-12
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
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KDJ
2022-03-18
15L Cycler Drainage Bag
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KDJ
2019-10-25
MiniCap Extended Life PD Transfer Sets
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KDJ
2018-05-21
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch
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KDJ
2018-02-14
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
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KDJ
2018-01-24
Cycler Drain Bag Set
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KDJ
2016-01-20
Firefly Peritoneal Dialysis Connector Disinfection System
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KDJ
2013-09-19
APD LUER-LOCK ADAPTER
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KDJ
2008-12-29
FRESENIUS STERILE STAY SAFE CAP
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KDJ
2004-11-05
K.E.P. CONNECTOR AND CLIP
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KDJ
2004-09-24
FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
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KDJ
2003-11-20
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
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KDJ
2003-03-05
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
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KDJ
1999-09-01
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
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KDJ
1997-10-01
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
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KDJ
1997-09-29
NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
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KDJ
1997-08-15
MEDISYSTEMS PERITONEAL DIALYSIS SETS
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KDJ
1996-08-06
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
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KDJ
1995-02-07
QC CAP
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KDJ
1994-08-31
RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
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KDJ
1994-03-28
ABBOTT SMART CAP
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KDJ
1994-02-22
BAXTER APD 12' EXTENSION LINE
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KDJ
1993-02-25
FRESENIUS VARIABLE FILL MONITOR
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KDJ
1992-09-21
DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET
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KDJ
1992-09-21
DEXTROLYTE II CAPD TRNSFER SET
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KDJ
1992-03-16
DEXTROLYTE II PERITONEAL DIALYSIS PUMP
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KDJ
1992-02-19
ABBOTT SMART CAP
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KDJ
1991-07-24
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
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KDJ
1991-01-11
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
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KDJ
1990-11-21
PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES
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KDJ
1990-11-20
90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET
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KDJ
1990-11-20
CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
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KDJ
1990-08-14
LONG-LIFE Y-SET CAT. NO. 48-6366-8
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KDJ
1990-07-16
CLOSED DISCONNECT SYSTEM
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KDJ
1990-03-23
CATHETER EXTENSION SET CAT. NO. 48-3027-9
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KDJ
1990-03-23
DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6
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KDJ
1990-03-22
PERITONEAL DIALYSIS CYCLER SET
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KDJ
1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6
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KDJ
1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3
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KDJ
1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6
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KDJ
1990-03-22
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2
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KDJ
1990-03-22
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6
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KDJ
1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3
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KDJ
1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
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KDJ
1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
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KDJ
1990-03-22
DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1
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KDJ
1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)
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KDJ
1990-03-22
PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6
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KDJ
1990-03-22
DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET
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KDJ
1990-03-02
DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1
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KDJ
1990-02-27
CATHETER ADAPTER SEALING CAP NO. 48-1028-9
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KDJ
1990-02-27
CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3
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KDJ
1990-02-27
QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3
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KDJ
1990-02-26
UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5
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KDJ
1990-02-26
CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1
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KDJ
1990-02-26
TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1
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KDJ
1990-01-29
CONNECTION SHIELDS CODES 5C4213 AND 5C4215
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KDJ
1990-01-29
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
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KDJ
1989-09-07
PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP
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KDJ
1989-07-24
PERITONEAL DIALYSIS SYSTEM AND ACCESS.
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KDJ
1989-06-08
DELCLAMP
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KDJ
1989-05-18
PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD
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KDJ
1989-05-18
PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD
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KDJ
1989-05-18
PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD
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KDJ
1988-11-03
CAPD DISPOSABLE Y SYSTEM - DY SET
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KDJ
1988-10-21
CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS
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KDJ
1988-07-13
EXTENDED LIFE CAPD TRANSFER SET 5C4444
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KDJ
1988-07-13
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
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KDJ
1987-10-20
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
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KDJ
1987-07-16
DELFLEX RIGID DRAIN CONTAINER
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KDJ
1987-07-09
MODIFIED LABELING FOR AMUKIN-50%
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KDJ
1987-06-03
FREEDOM SET II WITH TRIFLEX VALVE
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KDJ
1987-04-30
DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE
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KDJ
1987-04-10
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
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KDJ
1987-04-10
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
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KDJ
1987-03-10
EXTERNAL Y VALVE 5C4198
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KDJ
1986-04-07
CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186
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KDJ
1986-02-05
CAPD TRANSFER SET SPIKE 5C4363
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KDJ
1985-10-04
TRAVENOL CAPD Y SET 5C4354
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KDJ
1985-07-29
CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353
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KDJ
1985-04-08
COMPACT EXCHANGE DEVICE 5C4197
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KDJ
1985-04-08
EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153
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KDJ
1982-06-30
CARD U.V. GERMICIDAL CHAMBER II
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KDJ
1982-03-02
CAPD U.V. GERMICIDAL CONNECTION SYSTEM
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KDJ
1981-11-16
PERITONEAL DIALYSIS CYCLER SET
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KDJ
1981-10-19
PERITONEAL DIALYSIS CYCLER SET (8UNIT)
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KDJ
1981-10-19
PERITONEAL DIALYSIS DRAINAGE
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KDJ
1981-09-21
STERI-TRACT
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KDJ
1981-09-09
SPIKE GUARD
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KDJ
1981-06-12
GAMBRO PERITONEAL DIALYSIS FLUID LINES
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KDJ
1981-04-29
AMP PERITONEAL DIALYSIS PREP KIT
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KDJ
1981-03-24
CCPD 3 LITER DRAINAGE SET
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KDJ
1981-03-24
CCPD CYCLER SET
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KDJ
1981-03-24
CAPD EXCHANGE SET
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KDJ
1981-01-29
INPERSOL CAPD BAG PORT CLAMP
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KDJ
1980-10-10
INPERSOL-CAPD ADMINISTRATION SET
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KDJ
1980-08-12
PERITONEAL DIALYSIS CYCLER SET W/PUMP
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KDJ
1980-08-12
CLIRANS TE15 HOLLOW FIBER DIALYZER
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KDJ
1980-08-12
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
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