Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2028411

FEI Number

1000125241

Entity Name

REPROCESSING PRODUCTS CORPORATION (RPC)

City/State/Country

TUCSON, AZ, US

Establishment Address

1643 W Modern Ct, TUCSON, AZ 85705, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

REPROCESSING PRODUCTS CORPORATION (RPC) (Owner Number: 9004570)

Owner / Operator Contact Address

1643 W Modern Ct, --, Tucson, AZ 85705, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K962959

PMA Number

N/A

All Registered Proprietary Names

E-Z Chek® Residual Chlorine Test Strips - K100-0101B E-Z Chek® Ozone (in Water) Test Strips - K100-0111 Cable/Tubing Tie Wraps, Nylon 8 - D300-0251 Cable/Tubing Tie Wraps, Nylon 4 - D300-0250 Fistula Clamp - Red - 7001-3955R Fistula Clamp - Blue - 7001-3955B Fistula Clamp - Yellow - 7001-3955Y Fistula Clamp - Green - 7001-3955G Fistula Clamp Ultra Grip Cover - 7001-3956 - 25/bag Fistula Clamp - Green - XL - 7001-3955XL Fistula Clamp - White - 7001-3955 Polysoft Replacement. Shields - 7001-3961 - 12/pack Polysoft VisorShield Kit White - 7001-3960 Safety Face-Shield Kit, Red - 7001-3962 Replacement Shields 7" - 7001-3963 10/pack Safety Face-Shield Kit, White - 7001-3964 E-Z Chek® Blood Leak Test Strips - K100-0114 Sample Cup, 0 - 120 mL - K100-1100 Reprocessing Connector for Renatron w/O-ring - 7000-1051 Ozone Air Detector Tubes - 6733181 - 10/Pack Chlorine Detection Tubes - CH24301 Acetic Acid Detection Tubes - 6722101 Ozone (in air) Detection Tubes - 6733181 Delux Tube Opener - 6401200 Accuro-Deluxe Pump Kit w/Case - 4056443 Accuro Deluxe Pump Kit - 4056443 Acetic Acid Det Tubes - 6722101 - 10/pack Hydrogen Peroxide Detection Tubes - 8101041 Hyd Peroxide Det Tubes - 8101041 - 10/Pack Hydrochloric Acid Detection Tubes - CH29501 Tube Opener 7000 - 6401200 300ppm Water TDS Solution - S-0032 - 1L 150ppm Water TDS Solution - S-0031 - 1L 14 mS NaCl Conductivity Solution - S-0025 - 1L 100 mS NaCl Conductivity Solution - S-0028 - 500mL 1500ppm Water TDS Solution - S-0033 - 1L 50 mS NaCl Conductivity Solution - S-0027 - 1L 3000ppm Water TDS Solution - S-0034 - 1L 50 mS NaCl Conductivity Solution - S-0026 - 500mL 15ppm Water TDS Solution - S-0030 - 1L 1 mS NaCl Conductivity Solution - S-0021 - 500mL 30ppm Water TDS Solution - S-0029 - 1L 14 mS NaCl Conductivity Solution - S-0024 - 500mL 150 µS NaCl Solution - S-0019 - 500mL UV Maxpro20 UV Lamp - OS-602855 UV Lamp for SP-2 Unit - AQ-3011 UV Lamp for SL-10A Unit - AQ-3050 UV Lamp for SL-1 Unit - AQ-3084 7 pH Buffer Solution 500mL - S-0011 4 pH Buffer Solution 500mL - S-0010 10 pH Buffer Solution 500mL - S-0013 7 pH Buffer Solution 1L - S-0012 Luer, Female 5/32" Hose Barb - BF00-0010 Lure, Male 5/32" Hose Barb - BF00-0011 CathGuard Patient Protective Pocket - 7001-3920 - 100/case E-Z Chek® Residual Chlorine Test Strips - K100-0101B Blood Port Caps, Red - 7000-1001 - 100/bag Auto-Vent® Dialysate Port Caps - 7000-0005 Blood Port Caps, Red, 7000-1002 - 1000/bag Dialysate Port Caps - E-Z Grip®, Rigid Twist Lock - 7000-0009 Blood Port Caps - Twist Lock, ISO Fitting - 7000-1004 - 1000/bag Blood Port Caps - Twist Lock, ISO Fitting - 7000-1003 - 100/bag Recirculation Connectors (Lure Lock) - Sterile - 7001-3902W SaniGuard Dialysis Catheter Caps - Non-Injectable - Sterile - 7001-3915 E-Z Chek® 0 - 14 pH Test Strips - K100-0104 E-Z Chek® pH Test Strips, Citrate Dialysate - K100-0117CT E-Z Chek® pH Test Strips, Acetate Dialysate - K100-0117 E-Z Chek® 4.5 - 10 pH Test Strips - K100-0104.5 Tube Occluder - Forceps - Blue - 7001-3950 Tube Occluder - Forceps - Sky Blue - 7001-3950SB Tube Occluder - Forceps - Yellow - 7001-3950Y Tube Occluder - Forceps - Green - 7001-3950G Tube Occluder - Forceps - Red - 7001-3950R Tube Occluder - Forceps - White - 7001-3950W Hose Clamp, 1/4 5/8, SS - D300-0200 Hose Clamp, 7/16 1, SS - D300-0202 Hose Clamp, 5/16 7/8, SS - D300-0201 Cirta-Quik Citric Acid Powder, - J100-0408 - 408g/bag Cirta-Quik Citric Acid Powder, - J100-1000 - 1000g/bag Cirta-Quik Citric Acid Powder, - J100-190 -190g/bag Cirta-Quik Citric Acid Powder, - J100-0747 - 747g/bag Cirta-Quik 50% Citric Acid Powder, J100-0050 - 1756g/bottle Citra-Quik 20% Citric Acid Powder, J100-0020 - 824g/bag Tubing, Black, Natural - 3/16 x 3/8 - BT00-0100 Tubing, Black, PVC - 5/32 x 9/32 - 100' - BT00-0101 Tubing, Reinforced - 3/8 ID x .625 OD - per/foot Accu-Read Blood Pressure Cuff - Small Adult 1 tube - BP00-0105 - 5/case Accu-Read Blood Pressure Cuff - Thigh Adult 2 tube - BP00-2205 - 5/case Accu-Read Blood Pressure Cuff - Large Adult 1 tube - BP00-2120 - 20/case Accu-Read Blood Pressure Cuff - Small Adult 1 tube - BP00-0120 - 20/case Accu-Read Blood Pressure Cuff - Regular Adult 1 tube - BP00-1120 - 20/case Accu-Read Blood Pressure Cuff - Large Adult 1 tube - BP00-2105 - 5/case Accu-Read Blood Pressure Cuff - Regular Adult 1 tube - BP00-1105 - 5/case Accu-Read Blood Pressure Cuff - Thigh Adult 1 tube - BP00-3105 - 5/case Water Hardness Test Strip - K100-0102 DripLok Wash Bottle 500mL - 7000-3105 - 3/case DripLok Wash Bottle - 7000-2105 10" 0.2 Micron PES - 25103100021WG 20" 1 Micron - SDC252001 - 20/case 10" 0.2 Micron PP - PG10H100021 10" 0.2 Micron - PPPG10H100022 20 Polypropylene Microfiber Depth, 1 Micron - PX-01-20 20" 5 Micron - SWC252005 - 20/case 10 Polypropylene Big Blue, 5 Micron - AM-WP5BB97P 10 Polypropylene Microfiber Depth, 1 Micron - PX-01-10 10 Polypropylene Depth, 5 Micron - LD-05-10 20 Polypropylene Depth, 5 Micron - LD-05-20 10 Polypropylene Microfiber Depth, 5 Micron - PX-05-10 20" 0.2 Micron PES - 2510H200021WG 9-3/4 Polypropylene Microfiber Depth, 1 Micron - PX-01-9-3/4 9-7/8 Polypropylene Microfiber Depth, 5 Micron - PX-05-9-7/8 20" 0.2 micron 222/FLAT - AR0020S02A 20 Polypropylene Microfiber Depth, 5 Micron - PX-05-20 10 Polypropylene Big Blue, 1 Micron - AM-WP1BB97P 9-3/4 Polypropylene Microfiber Depth, 5 Micron - PX-05-9-3/4 20" 0.2 Micron PES - 25103200021WG 9-7/8 Polypropylene Microfiber Depth, 1 Micron - PX-01-9-7/8 10" 0.2 mic Vent PTFE - 34103100021G 20" 0.5 Mic CBC - AM-155309 - 6/case 20 Polypropylene Big Blue, 25 Micron - AM-WP25BB20P 10" 0.5 Mic CBC BB - AM-155170 - 4/case 20" 04 Micron PES - 2510H209241WG 10" 0.2 Micron PES - 2510H100021WG 20 Polypropylene Big Blue, 1 Micron - AM-WP1BB20P 20" 0.1 Micron PES - 251033200011WG 20 Polypropylene Big Blue, 5 Micron - AM-WP5BB20P 10 Polypropylene Big Blue, 25 Micron - AM-WP25BB97P 20" 04 Micron PES - 25103209241WG 10" 0.5 Mic CBC - AM-155162 - 12/case Universal Dialyzer Holder - S-10000 Universal Dialyzer Holder w/DC Post - S-10001 SoftCheck Blood Pressure Cuff - Infant -1 Tube - ST0814FLC - 20/case SoftCheck Blood Pressure Cuff - Small Adult -1 Tube - ST1826FLC - 20/case SoftCheck Blood Pressure Cuff - Thigh -1 Tube - ST4250FLC - 20/case SoftCheck Blood Pressure Cuff - Long Adult -1 Tube - ST2938FLC - 20/case SoftCheck Blood Pressure Cuff - Child -1 Tube - ST1320FLC - 20/case SoftCheck Blood Pressure Cuff - Large Adult -1 Tube - ST3242FLC - 20/case SoftCheck Blood Pressure Cuff - Regular Adult -1 Tube - ST2635FLC - 20/case SoftCheck Blood Pressure Cuff - Large Adult Long -1 Tube - ST3544FLC - 20/case Micro-X® Peracetic Acid Potency Test Strips - K100-0105 Micro-X® Disinfectant/Sterilant (1 gal) - MX-30004 Micro-X® Disinfectant/Sterilant (1 qt) - MX-3212

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FKJ	Filter, Blood, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2016-08-10
MSY	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant	Gastroenterology, Urology	Class 2	876.5665	2016-08-10
FKE	Tie, Dialysis	Gastroenterology, Urology	Class 1	876.5820	2024-07-24
NOO	Clamp, Dialysis Arm	Gastroenterology, Urology	Class 1	876.5540	2024-07-23
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-07-23
FJD	Detector, Leak, Blood	Gastroenterology, Urology	Class 2	876.5820	2016-08-10
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-07-24
LIF	Dialyzer Reprocessing System	Gastroenterology, Urology	Class 2	876.5820	2024-07-23
BXA	Analyzer, Gas, Water Vapor, Gaseous-Phase	Anesthesiology	Class 1	868.1975	2024-07-17
KIP	Formulations, Balanced Salt Solutions	Hematology	Class 1	864.2875	2024-07-23
KMG	Purifier, Water, Ultraviolet, Medical	General Hospital	Class 2	880.6710	2024-07-23
JCC	Ph Buffer	Pathology	Class 1	864.4010	2024-07-23
MON	System, Hemodialysis, Remote Accessories	Gastroenterology, Urology	Class 1	876.5820	2019-08-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2002-09-04
MSY	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant	Gastroenterology, Urology	Class 2	876.5665	2023-11-22
FJI	Dialyzer, Capillary, Hollow Fiber	Gastroenterology, Urology	Class 2	876.5820	2019-08-21
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2016-08-10
MNV	Strip, Dialysate Ph Indicator	Gastroenterology, Urology	Class 2	876.5820	2016-08-10
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-07-23
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2024-07-23
KDY	Agent, Chelating For Decalcification	Pathology	Class 1	864.4010	2024-07-23
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2024-07-24
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2019-08-27
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2019-05-22
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2024-07-23
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2024-07-22
FKI	Set, Dialyzer Holder	Gastroenterology, Urology	Class 2	876.5820	2024-07-23
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2019-08-27
LIF	Dialyzer Reprocessing System	Gastroenterology, Urology	Class 2	876.5820	2016-08-10
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2016-09-12

Official Correspondent

Brenda Lara

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

REPROCESSING PRODUCTS CORPORATION (RPC)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K864831	Cobe Laboratories, Inc.	COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS	1987-03-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2026	Fresenius Medical Care Holdings, Inc.	2	Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM

Similar Registrations

Registration Number	Establishment Name	Location
3010866895	NELSON ENVIRONMENTAL TECHNOLOGIES, INC.	Stafford, TX, US
2013736	MEDICAL CHEMICAL CORPORATION	TORRANCE, CA, US
2150060	Medivators Inc	MINNEAPOLIS, MN, US
1833387	SERIM RESEARCH CORP.	ELKHART, IN, US
1932668	MOLDED PRODUCTS INC.	HARLAN, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2028411. Last updated year: 2026. Please use registration number 2028411 when referencing this establishment in official correspondence.