FDA Registration
Active
🇺🇸 United States
REPROCESSING PRODUCTS CORPORATION (RPC)
Reg #: 2028411
·
FEI: 1000125241
·
Expires 2026
Products
30
Proprietary Names
165
Establishment Types
4
Classifications
30
Registration Details
- Registration Name
- REPROCESSING PRODUCTS CORPORATION (RPC)
- Registration Number
- 2028411
- FEI Number
- 1000125241
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1643 W Modern Ct
- City
- TUCSON
- State
- AZ
- ZIP
- 85705
- Country
- US
Regulatory Submissions
- 510(k) Number
- K901734
Owner / Operator
- Firm Name
- REPROCESSING PRODUCTS CORPORATION (RPC)
- Operator Number
- 9004570
- Address
- 1643 W Modern Ct, --
- City
- Tucson
- State
- AZ
- Postal Code
- 85705
- Country
- US
- Correspondent
- Brenda M Lara
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filter, Blood, Dialysis | FKJ | Class 2 | Gastroenterology, Urology | No | 2016-08-10 |
| Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | MSY | Class 2 | Gastroenterology, Urology | No | 2016-08-10 |
| Tie, Dialysis | FKE | Class 1 | Gastroenterology, Urology | No | 2024-07-24 |
| Clamp, Dialysis Arm | NOO | Class 1 | Gastroenterology, Urology | No | 2024-07-23 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2024-07-23 |
| Detector, Leak, Blood | FJD | Class 2 | Gastroenterology, Urology | No | 2016-08-10 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2024-07-24 |
| Dialyzer Reprocessing System | LIF | Class 2 | Gastroenterology, Urology | No | 2024-07-23 |
| Analyzer, Gas, Water Vapor, Gaseous-Phase | BXA | Class 1 | Anesthesiology | No | 2024-07-17 |
| Formulations, Balanced Salt Solutions | KIP | Class 1 | Hematology | No | 2024-07-23 |
| Purifier, Water, Ultraviolet, Medical | KMG | Class 2 | General Hospital | No | 2024-07-23 |
| Ph Buffer | JCC | Class 1 | Pathology | No | 2024-07-23 |
| System, Hemodialysis, Remote Accessories | MON | Class 1 | Gastroenterology, Urology | No | 2019-08-12 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2002-09-04 |
| Dialyzer, Capillary, Hollow Fiber | FJI | Class 2 | Gastroenterology, Urology | No | 2019-08-21 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2016-08-10 |
| Strip, Dialysate Ph Indicator | MNV | Class 2 | Gastroenterology, Urology | No | 2016-08-10 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-07-23 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2024-07-23 |
| Agent, Chelating For Decalcification | KDY | Class 1 | Pathology | No | 2024-07-23 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2024-07-24 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2019-08-27 |
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | JRS | Class 1 | Clinical Chemistry | No | 2019-05-22 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2024-07-23 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2024-07-22 |
| Set, Dialyzer Holder | FKI | Class 2 | Gastroenterology, Urology | No | 2024-07-23 |
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2016-09-12 |
| Label Or Tag, Non-Sterile | QMX | Class 1 | General, Plastic Surgery | No | 2024-07-17 |
| Solution, Decalcifier, Acid Containing | KDX | Class 1 | Pathology | No | 2024-07-23 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2024-07-23 |
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
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
Micro-X® Peroxide / Peracetic Acid Residual Test Strips - K100-0100
Renalog Lables for Zebra TLP 2844 Printer - 7000-2102
Dialyzer Labels, White - 7000-2001
Bar Code Label Protector - P/N 7000-2125
Bar Code Label Protector, Similar Name - 7000-2126
Name Alert® Lables - 7000-2300
Isopure Cleaner/High pH 4 oz - CH00402STEP2 - 12/case
Isopure Cleaner/Low pH 4 oz - CH00401STEP1 - 12/case
Flocon® TFC Acid Membrane Cleaner 4 lb - FLOMC20-16 - 4/case
Isopure/Portable RO/Low pH 4 oz - CH00101STEP1 - 12/case
ProbeRite® Sensor Cleaning Solution 500mL - S-0043
ProbeRite® Sensor Cleaning Solution 1L - S-0044
Isopure MD400 RO HydroBLAST Enhancer - CH30001SALT - 24/case
Flocon® TFC Alkaline Membrane Cleaner 50 lbs - FLOMC10-5
Isopure/Portable RO/High pH 4 oz - CH00102STEP2 - 12/case
Flocon® TFC Alkaline Membrane Cleaner 4 lb - FLOMC10-16 - 4/case
Flocon® TFC Acid Membrane Cleaner 50 lbs - FLOMC20-5
Isopure Portable RO HydroBLAST Enhancer - CH30002SALT - 24/case
PeriScreen Test Strip - 5122 - 25/Bottle
Ultra-Low Total Chlorine Test Strips - K100-0118
Ultra-Low Total Chlorine Test Strips - K100-0118F
Ultra-Low Chlorine Color Chart - 480007-FMC-CC
Ultra-Low Chlorine Color Chart - 480007-CC
E-Z Chek® Sensitive Total Chlorine and Chloramines Test Strips - K100-0106
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device